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Clinilabs Drug Development Corporation Begins Enrollment for Phase 1/2a Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder

Clinilabs Drug Development Corporation Begins Enrollment for Phase 1/2a Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder

07/12/2022

EATONTOWN, N.J.–(BUSINESS WIRE)– Clinilabs Drug Development Corporation (“Clinilabs”), a global, full-service contract research organization with deep expertise in central nervous system drug development, announced today that enrollment has begun in a Phase 1/2a clinical trial of CYB003, the first novel psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder (“MDD”). CYB003 is being developed by Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin”), a leading ethical biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”.

Cybin announced that it received Investigational New Drug clearance from the U.S. Food and Drug Administration for the Phase 1/2a trial at the end of June, marking the industry’s first novel psilocybin analog to enter clinical development.

“Clinilabs is honored to be working with Cybin, an innovator in the development of novel psychedelic therapeutics, to conduct its first-in-human clinical trial of CYB003,” said Jeanine Falinski, Vice President of Strategy and Corporate Development at Clinilabs. “We are excited by the potential of these therapeutics and hope that the future is life-changing for individuals suffering from mental illness. We are encouraged by the interest from potential research participants who have already come forward prior to today.”

“Successful patient recruitment and a proper clinical environment are integral components of this trial. As a global leader in drug development services, Clinilabs is a perfect partner and we are thankful for their support and guidance,” said Doug Drysdale, Chief Executive Officer of Cybin.

About the CYB003 Phase 1/2a Trial

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. Participants will receive two administrations of the study drug and a response/remission will be assessed at Week 3 (after first dose) and at Week 6 (after second dose). Importantly, participants in the trial that are currently being treated with selective serotonin reuptake inhibitors will be allowed to remain on their antidepressant medication.

Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the incremental benefit of a second dose of CYB003 when administered at Week 3 and will provide important PK and safety data to determine a clinical path forward. An optional period of assessment will help determine the durability of treatment effect out to 12 weeks. The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.

This research study is recruiting individuals between the ages of 21 and 55 who have been diagnosed with MDD and who are currently taking an SSRI or SNRI that is not working to their satisfaction. Participation includes 11 outpatient visits and two 2-day inpatient stays. Compensation may be up to $4,335 including travel. Participants who are located within reasonable travel distance to the Clinilabs Eatontown, New Jersey clinical research unit, may pre-screen for study entry at www.depressionpsychedelicstudy.com or by telephone at (212) 994-4567.

About CYB003

CYB003 is a deuterated analog of psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, CYB003 can easily activate the serotonin 5-HT2A receptor.

CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect. We believe CYB003 has the potential to reduce time and resource burden on patients, providers, and payers, and possibly improve scalability and accessibility​ of treatment.

About Clinilabs Drug Development Corporation

Clinilabs Drug Development Corporation is the only global, full-service contract research organization (CRO) focused exclusively on central nervous system (“CNS”) drug development. With deep expertise in CNS, we are committed to the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as rare and ultra-rare CNS diseases. Clinilabs partners with pharmaceutical and biotechnology companies to deliver a complete, first-in-human to Phase 3 spectrum of high quality, timely, and cost-effective clinical drug development services, with the shared goal of speeding new CNS medicines to market. We are process-driven yet structured to be nimble, providing personalized service that meets the needs of customers and projects of all sizes. Clinilabs has conducted more than 675 CNS clinical trials in our 22-year history and played a pivotal role in the approval of 19 new therapies across 10 CNS indications to help transform the lives of patients worldwide.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements related to the results of the Company’s CYB003 preclinical studies, statements regarding the Company’s CYB003 Phase 1/2a trial and anticipated results, the Company’s plans to start recruiting patients immediately for its CYB003 Phase 1/2a trial,, and the Company’s plan to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the year ended March 31, 2022 and the Company’s annual information form for the year ended March 31, 2022, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media Contacts:

Jeanine M. Falinski, MBA
Vice President, Strategy & Corporate Development
Clinilabs Drug Development Corporation
jfalinski@clinilabs.com

Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.com

Source: Clinilabs Drug Development Corporation

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BetterLife Secures Additional Mitacs Funding in Collaboration with Carleton University Research Team for BETR-001 Preclinical Depression Studies

BetterLife Secures Additional Mitacs Funding in Collaboration with Carleton University Research Team for BETR-001 Preclinical Depression Studies

VANCOUVER, British Columbia, July 06, 2022 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, is pleased to announce that a joint application to the Mitacs Accelerate program, in collaboration with Dr. Argel Aguilar-Valles at Carleton University (Carleton) Department of Neuroscience, was successfully funded for research into the anti-depressant effects and mechanism of action (“MOA”) of BETR-001 in preclinical models of depression.

BETR-001 is a second-generation Lysergic Acid Diethylamide (“LSD”) derivative molecule that BetterLife believes will mimic the therapeutic potential of LSD without causing psychedelic effects, such as hallucinations.

“BETR-001 is a potential novel therapy to treat debilitating psychiatric disorders with high unmet need, such as treatment-resistant severe depression and cluster headaches. BetterLife’s goal is to bring this treatment to Investigational New Drug (“IND”) application and the clinic as soon as possible, and the scientific expertise of Carleton University’s team, headed by Dr. Argel Aguilar-Valles at the Department of Neuroscience, is an ideal partner to help us realize our vision,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian.

As part of the funded Mitacs Accelerate Program, Dr. Argel Aguilar-Valles (Principal Investigator) and Dr. Vern Lewis (Postdoctoral Fellow) will continue to work with the BetterLife team to assess the efficacy and MOA of BETR-001 in depression models established in their lab.

About BetterLife Pharma

BetterLife Pharma Inc. is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuro-psychiatric and neurological disorders.

BETR-001, which is in preclinical and IND-enabling studies, is a non-hallucinogenic and non-controlled LSD derivative in development and it is unique in that it is unregulated and therefore can be self-administered. BetterLife’s synthesis patent for BETR-001 eliminates regulatory hurdles and its pending patent for composition and method of use covers treatment of depression, cluster headaches, post-traumatic stress disorder and other neuro-psychiatric and neurological disorders.

BETR-002, which is in preclinical and IND-enabling studies, is based on honokiol, the active anxiolytic ingredient of magnolia bark. BetterLife’s pending method of use and formulations patent covers treatment of anxiety related disorders including benzodiazepine dependency.

BetterLife also owns a drug candidate for the treatment of viral infections such as COVID-19 and is in the process of seeking strategic alternatives for further development.

For further information, please visit BetterLife Pharma.

About the Department of Neuroscience at Carleton University

Carleton Neuroscience has an international reputation for research on stress and its effects on brain functioning and mental health. The department has an interdisciplinary approach to understanding the emergence, prevention and treatment of mental and physical disorders.

For more information, please visit www.carleton.ca/neuroscience.

About Mitacs

Mitacs is a national, not-for-profit organization that has designed and delivered research and training programs in Canada for 20 years. Working with an extensive network of postsecondary partners, and both federal and provincial governments, we build collaborations that support industrial and social innovation in Canada. Mitacs has worked with thousands of private sector and not-for-profit organizations as well as 78 universities and 77 college, CÉGEP and polytechnic partners to fuel strategic relationships that power Canadian innovation excellence.

To learn more about the organization, please visit https://www.mitacs.ca/en.

Contact Information

David Melles, Investor Relations Manager
Email: David.Melles@blifepharma.com
Phone: 1-778-887-1928

Cautionary Note Regarding Forward-Looking Statements

No securities exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Cybin Receives FDA IND Clearance for its Phase 1/2a Clinical Trial Evaluating CYB003 for the Potential Treatment of Major Depressive Disorder

Cybin Receives FDA IND Clearance for its Phase 1/2a Clinical Trial Evaluating CYB003 for the Potential Treatment of Major Depressive Disorder

06/27/2022

— Marks the first novel psilocybin analog to enter clinical development —
— Patient recruitment to commence immediately —
— Pharmacokinetic and safety data readout expected in Q4 2022 —

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced that it has received a “may proceed letter” and Investigational New Drug Application (“IND”) clearance from the U.S. Food and Drug Administration (“FDA”) for its Phase 1/2a first-in-human clinical trial evaluating CYB003. CYB003 is a proprietary deuterated psilocybin analog that is being developed for the potential treatment of major depressive disorder (“MDD”). This milestone marks the industry’s first ever novel psilocybin analogto enter clinical development. The Company will begin recruiting patients immediately and expects to provide an interim pharmacokinetic (“PK”) and safety data readout in Q4 2022.

“We are extremely pleased to advance CYB003 into clinical development so quickly. Our team has worked diligently to achieve this major regulatory milestone and we look forward to collaborating with Clinilabs, our drug development partner, to accelerate this program,” said Doug Drysdale, Chief Executive Officer of Cybin. “This Phase 1/2a trial represents the first time that a psilocybin analog will be evaluated for the treatment of MDD and is the key next step toward our ultimate goal of providing a new and effective treatment for people suffering with mental health conditions.”

About the CYB003 Phase 1/2a Trial

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. Participants will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after first dose) and at Week 6 (after second dose). Importantly, participants in the trial that are currently being treated with selective serotonin reuptake inhibitors will be allowed to remain on their antidepressant medication.

Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the benefit of CYB003 when administered at up to two doses of 12mg and will provide important PK and safety data to determine a clinical path forward. An optional open-label follow-up study will assess the durability of treatment effect out to 12 weeks.

The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.

About CYB003

CYB003 is a deuterated analog of psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor.

CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect. We believe CYB003 has the potential to reduce time and resource burden on patients, providers, and payers, and possibly improve scalability and accessibility​ of treatment.

Preclinical Results for CYB003

In multi-species preclinical studies, CYB003 demonstrated:

  • a well-tolerated profile following several doses in multiple species that supports repeat dosing in humans;
  • a similar in vitro and in vivo pharmacology profile when compared to psilocin, the active naturally occurring psychedelic agent in psilocybin;
  • a 50% reduction in variability compared to classic psilocybin, indicating the potential for more accurate dosing;
  • a 50% dose reduction compared to classic psilocybin, indicating the potential to maintain equivalent efficacy while reducing side effects;
  • a 50% shorter time to onset when compared to classic psilocybin, indicating the potential for shorter duration of treatment, lower inter-subject variability, and better therapeutic control; and,
  • nearly double the brain penetration when compared to classic psilocybin, indicating the potential for a less variable treatment response.

“Multiple academic studies have shown that psychedelic-based treatments, like psilocybin, may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin. We believe CYB003 has the potential to offer people in need with a more tolerable and potentially more effective treatment option. We look forward to advancing this important compound through clinical development,” concluded Drysdale.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements related to the results of the Company’s CYB003 preclinical studies, statements regarding the Company’s CYB003 Phase 1/2a trial and anticipated results, the Company’s plans to start recruiting patients immediately for its CYB003 Phase 1/2a trial, the Company’s plans to readout interim PK and safety data by the end of 2022, and the Company’s plan to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the year ended March 31, 2022 and the Company’s annual information form for the year ended March 31, 2022, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Invest or & Media : 

Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.

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Children took ayahuasca in ancient Incan ritual

Ritual drug use during Inca human sacrifices on Ampato mountain (Peru): Results of a toxicological analysis

A new study suggests that children in the Incan empire took psychedelics to ease stress before being sacrificed.

Archaeologists discovered the 500 year old remains of two Incan children who were sacrificed as part of a ritual called capacocha.

Capacocha was a common ceremony performed to appease the gods for a variety of purposes, such as to prevent natural disasters.

Toxicology samples revealed that the children, who were around the age of 6, consumed coca leaf and ayahuasca in the final weeks of their lives.

According to the study authors, “the Incas may have consciously used the antidepressant properties of (ayahuasca) to reduce the anxiety and depressive states of the victims.”

PDF of article

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PharmaTher Announces Positive Results from Study of KETABET™ for Depression

PharmaTher Announces Positive Results from Study of KETABET™ for Depression

KETABET™ (Ketamine and Betaine) shown effectiveness as measured by the Clinician Administered Dissociative States Scale

Study results are adequate to give an effect size in powering a placebo-controlled clinical study

PharmaTher planning a Phase 2 clinical study to incorporate KETABET™ in its proprietary microneedle patch for depressionTORONTO, June 7, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce positive results from an investigator-led observational study (the “Study”) evaluating the impact of KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression. KETABET™ aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.

The investigator-led observational study is a randomized crossover study with subjects suffering from unmanageable depression and currently receiving ketamine treatment but experiencing unwanted side effects of ketamine. The study enrolled 10 subjects and aimed to determine if the administered oral betaine anhydrous before ketamine treatment can reduce some or all of the unwanted side effects observed in the first few hours of ketamine therapy as determined by the Clinician Administered Dissociative States Scale (“CADDS”). Alleviation or reduction of side effects support further progression of this product strategy. The CADDS is currently the standard scale used for studies assessing acute psychoactive effects of ketamine. It is used to measure present-state dissociative symptoms and assess treatment-emergent dissociative symptoms. The CADDS is comprised of 23 questions each evaluated on a 5-point scaling system (0 = “not at all”, 1 = “mild”, 2 = “moderate”, 3 = “severe”, and 4 = “extreme”). Assessment is based on three components, including depersonalization, derealization and amnesia, and an overall total score representing the severity of the condition. Depersonalization is a state in which one loses a sense of identity relative to thoughts and feelings. Derealization is a state where one feels detached from their surroundings.

The Study’s data support the benefit of pre-treatment with oral anhydrous betaine prior to ketamine administration for certain side effects measured by CADDS, including depersonalization and derealization. A reduction in mean of 66% at 40 minutes following ketamine infusion initiation was seen for each of these measures in the Study. Ketamine and betaine were well tolerated with no serious adverse events reported. Although the Study was not meant for statistical significance, it supports the Company’s planned placebo-controlled phase 2 clinical study incorporating KETABET™ in the Company’s proprietary microneedle patch and will further evaluate betaine anhydrous dose, timing of pre-treatment, and duration of effect on depersonalization and derealization effects of low-dose ketamine. Reduction in the depersonalization and derealization side effects associated with low-dose ketamine infusion will potentially improve treatment compliance, treatment dose range, and treatment duration associated with ketamine therapy. Additional influence of pre-treatment with betaine prior to low-dose ketamine administration will further define the Company’s KETABET™ product scope for this and potentially other indications. Complete results of the Study are expected to be submitted for presentation at a medical congress by 2H-2022.

Dr. Raul Cruz, MD, Principal Investigator of the Study, commented: “The results of this pilot observational study were very promising as the pre-treatment with betaine prior to ketamine administration demonstrated a better recovery from ketamine effects and higher dose tolerability for patients that typically experience dose limiting side effects. In general, patients that typically experienced nausea during treatment had a notable reduction and improved recovery. We are encouraged by the increase in alertness and decreased dizziness with pre-treatment of betaine and look forward to incorporating this combination into our practice for patients that require ketamine therapy for depression.”      

Fabio Chianelli, CEO of PharmaTher, commented: “We are very pleased with the results from this Study as it provides support for advancing our microneedle patch program in a potential Phase 2 clinical study evaluating KETABET™ for mental health and pain disorders.”

Based on the Study results, the Company is preparing to engage the FDA to establish the next steps for a planned Phase 2 clinical study to allow for KETABET™ evaluation in depression under the 505(b)(2) regulatory pathway. The Company intends to use its proprietary hydrogel-forming microneedle patch for the planned Phase 2 clinical study.

Granted patents of KETABET™ are issued in the U.S. (Patent No. 11,213,495), Japan (Patent no. 6967532) and Taiwan (Patent no. I648049). The Company expects to convert the current patent applications in Europe, Canada, Israel and China into granted patents. Patent protection is expected to expire in 2036.

Potential of KETABET™

KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.1 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.2  The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine.1  This suggests that betaine anhydrous can be considered as an add-on therapy to ketamine or as a fixed-dose combination therapy for treatment-resistant depression, treatment-resistant bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder and chronic pain.

More than 300 million people suffer from major depressive disorder and 100 million people are resistant to available treatments worldwide.  Ketamine is emerging as a viable treatment option for depression. Recent clinical studies have shown that low dose ketamine produces a rapid-acting and sustained antidepressant effect in major depressive disorder,3 bipolar depression,4 depression with suicidal ideation5 and post-traumatic stress disorder.6 Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine leads to its limited clinical use and discontinuation.

Betaine anhydrous (CYSTADANE®) was approved by the FDA in 1996 to treat homocystinuria to decrease elevated homocysteine blood concentrations. There is growing evidence that betaine plays a critical role in regulating brain functions and has an antidepressant-like effect.7 Betaine has been reported to prevent seizures in rodents,8 to improve symptoms of Rett syndrome,9 and to delay the onset of neurologic impairment due to vitamin B12 deficiency10 clinically.  Furthermore, betaine attenuates memory deficits induced by homocysteine.11

Potential of the Hydrogel-forming Microneedle Patch

The Company’s patented hydrogel-forming microneedle (“MN”) patch aims to deliver ketamine and KETABET™ for intradermal administration to treat various mental health, neurological and pain disorders. The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.12 The MN patch is specifically tailored for ketamine and KETABET™ due to the volume of drug that is required to maximize their therapeutic utility and increase potential market opportunities.

The KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office. KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.12-13 Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. Learn more at PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the three and nine month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 2022, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Sources:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32
  2. Krystal et al. 1994; Perry et al. 2007
  3. Murrough et al. 2013; Wan et al. 2014
  4. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
  5. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
  6. Feder et al. 2020
  7. ​Freed 1984; 1985
  8. Kim et al. 2013; Di Pierro et al. 2015
  9. Percy and Lane 2005
  10. van der Westhuyzen and Metz 1984
  11. ​Chai et al. 2013
  12. Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
  13. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
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Women-focused psilocybin study for depression

A New Clinical Trial in South Africa Aims to Study the Effect of Psilocybin on HIV Positive Women with Major Depressive Disorder

Women are nearly twice as likely to be diagnosed with depression than men, but they’re often underrepresented in clinical trials.

Additionally, individuals with chronic illnesses like HIV often suffer from depression as well, which can make them less likely to adhere to their medications.

That’s why Cannsun Medicinal Global is investigating psilocybin as a treatment for depression in women who are HIV-positive.

The phase 2 trial received approval and will begin next month in South Africa.

“It is vitally important to have a deeper understanding of how women respond to medical treatment for major depression versus men in order to develop psychedelic therapies and treatment protocols for women that have clinically significant outcomes that are safe and effective,” says Donaghue Woodman, the company’s Head of R&D and Chief Medical Information Officer.

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Why ketamine reduces depression so quickly

Why ketamine is a speedster antidepressant

Several studies have found that ketamine produces a rapid antidepressant effect, reducing suicidal ideation in just hours.

A new study from Northwestern University sheds light on why the benefits are so instantaneous.

Traditional antidepressants work by increasing the number of neurons in the brain, which can take several weeks.

Ketamine, on the other hand, was found to increase activity in newborn neurons, which then activates other cells in the hippocampus.

“This small population of cells acts like a match, starting a fire that ignites a bunch of activity in a lot of other cells that produce the behavioral effects,” says lead study author Dr. John Kessler.

“That’s important because when you give ketamine to patients now, it affects multiple regions of the brain and causes a lot of adverse side effects. But since we now know exactly which cells we want to target, we can design drugs to focus only on those cells.”

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PDF of study

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Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder

Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder

— CYB003 is the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder —

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, is pleased to announce the submission of an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its Phase 1/2a first-in-human clinical trial evaluating CYB003, a proprietary deuterated psilocybin analog, for the treatment of major depressive disorder (“MDD”).

“Following the successful completion of our IND-enabling work just last month, we are very excited to have reached this major milestone toward advancing CYB003 into clinical development so quickly. Based on preclinical studies, our proprietary psilocybin analog has the potential to offer numerous advantages over classic psilocybin with the potential to ultimately provide better outcomes for people suffering with MDD,” said Doug Drysdale, Chief Executive Officer of Cybin. “This FDA submission is the next major step in the advancement of CYB003, and we continue to work tirelessly to bring this innovative therapeutic option to people as quickly as possible. We look forward to continuing to work with the FDA to initiate the Phase 1/2a trial in mid-2022.”

About the CYB003 Phase 1/2a Trial
The Phase 1/2a trial is a randomized, double blind, placebo-controlled study evaluating people with moderate to severe MDD. Subjects will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after single dose) and at Week 6 (after receiving a second dose). Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the benefit of more than one administration and will provide pharmacokinetic (“PK”) and safety data. The trial design will allow for people to continue their treatment with selective serotonin reuptake inhibitors (“SSRIs”). An optional open-label follow-up study (up to 12 weeks) will allow an assessment of durability of treatment effects.

“Through this Phase 1/2a trial, we are primarily looking to demonstrate the improved PK and safety profile of CYB003, as well as efficacy. We have designed the trial to allow people to continue to take their antidepressant medication, which will also allow us to assess the effect of CYB003 on people who are treated with an SSRI. At this time, we expect to have a PK and safety data readout by the end of 2022,” concluded Drysdale.

The Company has engaged Clinilabs Drug Development Corporation, a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Phase 1/2a clinical trial of CYB003.

The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.

About CYB003
CYB003 is derived from psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability. CYB003 has the potential to effectively treat MDD and alcohol use disorder.

About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the NEO Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin

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Biomind Receives Approval for a Third Phase II Clinical Trial for Its 5-MeO-DMT Based BMND08 Candidate for Depression & Anxiety in Alzheimer’s Disease

Biomind Receives Approval for a Third Phase II Clinical Trial for Its 5-MeO-DMT Based BMND08 Candidate for Depression & Anxiety in Alzheimer’s Disease

May 26, 2022 07:25 AM Eastern Daylight Time

TORONTO–(BUSINESS WIRE)–Biomind Labs Inc. (“Biomind Labs” or the “Company”) (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological and psychiatric disorders by scientifically harnessing the medicinal power of psychedelic molecules, is pleased to announce that a third Phase II clinical trial for its BMND08 candidate based on 5-Methoxy-N,N-dimethyltryptamine (“5-MeO-DMT”) for treatment of depression and anxiety in patients with Alzheimer’s-type cognitive impairment has been approved by the Argentinian Institutional Review Board.

“As we continue to move forward with our efforts in identifying indications where we can provide significant improvement in patients suffering from mental health, we are more than pleased to announce the approval of a Phase II clinical trial for our BMND08 novel drug candidate which may allow us to address a new line of development to attenuate depression and anxiety states in patients with Alzheimer’s-type cognitive impairment,” commented Alejandro Antalich, CEO of Biomind Labs.

“Since our inception, neurodegenerative diseases were on the list of indications we wanted to tackle. We can now address such indications using a novel approach that uses a fast-acting psychedelic molecule capable of providing relief to certain mood states when Alzheimer’s disease first appears in patients. After a thorough analysis on the potential benefit of using a psychedelic molecule to alleviate certain symptoms in Alzheimer’s patients, we concluded that the most suitable candidate from our portfolio was BMND08, an oral formulation of 5-MeO-DMT.”

“Given the significant morbidity rate associated with Alzheimer’s disease such as agitation, apathy, sleep disturbances and anxiety, it became clear to us that novel approaches to treat Alzheimer’s-type cognitive impairment are urgently needed. The Phase II clinical trial will test Biomind’s psychiatry intervention-based model, allowing a rapid and feasible merge of fast-acting psychedelic medicines into clinical practices already in existence.”

“It is an honour for us to be working together with Neuroscientist Dr. Martín A. Bruno and a highly professional interdisciplinary medical team who will be in charge of conducting this Phase II clinical trial.”

“While the current practice guidelines consistently refer to the management of symptoms as central to the treatment of Alzheimer’s disease, the lack of established effective treatments continues to motivate us to generate novel therapeutic solutions”, concluded Antalich.

About Biomind Labs Inc. 

Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of the main psychedelic molecules, N,N-Dimethyltryptamine, 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to provide patients access to affordable and modern-day treatments.

Cautionary Note Regarding Forward-Looking Statements 

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this document include, among others, statements relating to the Company’s ability to scientifically harness the medicinal power of psychedelic molecules to treat patients suffering from neurological and psychiatric disorders, any timeframes and possible results of the Phase II clinical trial of the Company’s novel drug candidate BMND08, including but not limited to its ability to attenuate depression and anxiety states in patients with Alzheimer’s-type cognitive impairment and to provide relief to certain mood states when Alzheimer’s disease first appears in patients, the Company’s rapid and feasible merge of fast-acting psychedelic medicines into clinical practices already in existence, the Company’s ability to provide patients access to affordable and modern-day treatments, and other statements that are not historical facts.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company’s business and results of operations; (d) the stock markets have experienced volatility that often has been unrelated to the performance of companies and these fluctuations may adversely affect the price of the Company’s securities, regardless of its operating peers; (e) adverse changes in the public perception of tryptamine-based treatments and psychedelic-based therapies; (f) the impact of COVID-19; and (g) general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments, psychedelic-based therapies or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psychedelic tryptamines, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed commercial clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the Company verified such in commercial clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

The forward-looking information contained in this news release represents the expectations of the Company as of the date of this news release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. The Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

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Toad venom for Grandma

Biomind Receives Approval for a Third Phase II Clinical Trial for Its 5-MeO-DMT Based BMND08 Candidate for Depression & Anxiety in Alzheimer’s Disease

Could Alzheimer’s patients benefit from one of the most powerful psychedelics? 

Biomind Labs (BMND) will find out in an upcoming study.

The Phase 2 trial, which was just approved by the Argentinian Institutional Review Board, will see if 5-MeO-DMT (a psychedelic found in the venom of the Sonoran Desert toad) can ease depression and anxiety in patients with Alzheimer’s disease.

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