MindMed’s LSD-based compound received FDA clearance, allowing the company to proceed with a trial that will be the first commercial study of LSD in over 40 years.
The study will assess 200 patients with generalized anxiety disorder to find the optimal dose of the formulation.
Shares of MNMD spiked 30% following the announcement 💰
FDA has issued a clinical hold on initial IND submission required to initiate Phase 2b trial of LSD for the treatment of generalized anxiety disorder
NEW YORK, Dec. 21, 2021 /PRNewswire/ — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its IND submission intended to support the initiation of a Phase 2b trial of lysergic acid diethylamide (LSD) for the treatment of generalized anxiety disorder (GAD). Additional detail regarding the FDA’s decision is expected within 30 days.
“Our team has a tremendous sense of urgency to bring new treatments, such as LSD, to the many patients in need, particularly given the growing mental health epidemic,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We remain highly confident in the therapeutic potential of LSD to usher in a new treatment paradigm for these disorders and we look forward to working closely with FDA to satisfy all outstanding concerns as rapidly as possible.”
About GAD
GAD is a chronic, often debilitating mental health disorder that affects approximately 6% of U.S. adults in their lifetimes. Symptoms of GAD include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National Institute of Mental Health (NIMH). While there is substantial diagnostic overlap between GAD, Major Depressive Disorder and other major mental health disorders, there has been very little innovation focused on the treatment of GAD in the past several decades.
About MindMed
MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental health and addiction. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies.
MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.
Forward-Looking Statements
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the therapeutic potential of LSD and the ability to initiate a Phase 2b trial of LSD for the treatment of GAD, the expected timing of additional information regarding the FDA’s decision and working closely with the FDA to satisfy all outstanding concerns as rapidly as possible. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
How Do Psychedelics Change Your Personality? These Researchers Tried To Find Out
Researchers developed a personality model to test how psychedelics affect the qualities that help us build and maintain healthy relationships.
They discovered that after taking psychedelics, participants felt:
How do you see psychedelics changing your relationships?
– Expands intellectual property portfolio and strengthens position as leading innovator in developing putative psychedelic compounds –
TORONTO–(BUSINESS WIRE)– Cybin Inc. ( NEO:CYBN) ( NYSE American:CYBN) (“ Cybin” or the “ Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics TM” today announced that it has been awarded a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for patent application No. 17/394,038 related to CYB004, the Company’s investigational deuterated psychedelic tryptamine compound for the potential treatment of anxiety disorders. The allowed claims include other forms of deuterated psychedelic tryptamine, notably certain deuterated forms of DMT and 5-MeO-DMT. The patent, which is expected to expire in 2041 before consideration of any patent term extensions, covers composition of matter for the CYB004 drug substance as a putative new chemical entity.
“The receipt of this Notice of Allowance from the USPTO represents an important milestone in expanding our intellectual property portfolio progressing psychedelics to therapeutics for the countless patients in need, and strongly demonstrates the Company’s dedication to the discovery and development of differentiated psychedelic-based compounds for addressing mental health,” said Doug Drysdale, Chief Executive Officer of Cybin. “Once issued, this patent may have the opportunity to cover a broad range of claims supporting our IP in psychedelic medicine and further strengthen our emerging best-in-class position in this evolving industry.”
According to the U.S. National Institute of Mental Health, anxiety disorders are one of the most common mental illnesses in the U.S., affecting 40 million adults, or approximately 18% of the population every year1. Despite the availability of many prescription medicines, these treatments are not equally efficacious in all patients with up to 50% of patients with general anxiety disorder failing to respond to first line treatments2. Current standardized treatments for anxiety disorders also require chronic administration of medicines that have a long time to onset and present several potential side effects including weight gain, gastrointestinal disturbances, sexual dysfunction and withdrawal symptoms.
“CYB004 is a proprietary deuterated psychedelic tryptamine that has the potential to effectively treat anxiety disorders without the well-known side effects of the current treatment landscape,” concluded Drysdale.
Cybin continues to pursue multiple opportunities to secure and support its patent position for research and development evaluating deuterated tryptamines for future psychedelic-based treatments for mental illnesses.
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. Patent filings described herein are held by Cybin IRL Limited, a wholly owned subsidiary of Cybin.
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 September 30, 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.
| 1) | Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015;17(3):327-335. doi:10.31887/DCNS.2015.17.3/bbandelow | |
| 2) | Ansara ED. Management of treatment-resistant generalized anxiety disorder. Ment Health Clin. 2020;10(6):326-334. Published 2020 Nov 5. doi:10.9740/mhc.2020.11.326 |
Investor & Media Contacts:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.comSource: Cybin Inc.
Quantified Citizen is a platform made in collaboration with Paul Stamets to accelerate health research. It allows anyone to participate in studies anonymously from their phone.
The platform was used to conduct the world’s largest mobile microdosing study, which revealed that microdosers exhibit lower levels of depression, anxiety, and stress.
It’s not too late to participate – download the app here to join the study!
A recent survey shows that spirituality increases with psychedelic use, and that increased spirituality is linked to improved emotional regulation. The findings suggest that better emotional regulation is associated with decreased scores for depression, anxiety, and disordered eating.
COMPASS Pathways (CMPS) announced additional findings from the world’s largest psilocybin trial for depression.
In addition to reduced depression scores, patients showed improvements in anxiety, daily functioning, cognition, and quality of life. Just one day after the treatment, patients had increased positive feelings such as “interested, excited, strong” and decreased negative feelings like “distressed, upset, afraid.”
Do patients need to come off of antidepressants before trying psilocybin therapy?
New research from MindMed (MNMD) and Liechti Labs suggests that it’s not necessary – and there are actually benefits of combining the two.
Escitalopram (aka Lexapro) did not affect the way psilocybin was processed and helped reduce negative side effects like anxiety and high blood pressure.
– Trial to be conducted at University of Washington, led by Dr. Anthony Back –
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 the U.S. Food and Drug Administration (“FDA”) has authorized and investigator-initiated randomized, placebo-controlled Phase 2 clinical trial evaluating psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing COVID-related distress. The trial will be conducted at the University of Washington and will aim to treat symptoms of depression, anxiety, burnout and post-traumatic stress among frontline doctors, nurses and healthcare professionals. The trial’s Primary Investigator, Dr. Anthony Back, received an investigational new drug (“IND”) approval letter from the FDA, which provides authority to proceed with the Phase 2 trial.
Further to the authorization from the FDA, the study has also received Institutional Review Board (“IRB”) approval at the University of Washington. This investigator-initiated trial will be hosted in Seattle, a city significantly impacted by the COVID-19 pandemic and will be funded by multiple organizations.
“This study offers an important opportunity to assess psychedelics-assisted therapy as a new modality for clinicians who have suffered as a result of their frontline work in the pandemic,” said Dr. Anthony Back.
To support the initiative, Cybin’s Chief Clinical Officer, Alex Belser, PhD and Bill Brennan, PhD (candidate) developed EMBARK, a six-domain model of psychedelic-assisted psychotherapy. EMBARK was designed as a transdiagnostic psychotherapy model that can be adapted to address a range of clinical indications and populations. In collaboration with Dr. Anthony Back and Ladybird Morgan, RN, MSW, an adapted version of EMBARK has been co-authored to treat COVID-related burnout and symptoms of depression among frontline healthcare workers, and this version includes material that specifically addresses cultural inclusion anticipating a diverse population of clinicians. Cybin launched the EMBARK Psychedelic Facilitator Training Program for study facilitators in October 2021.
“Throughout the COVID-19 pandemic, nurses, doctors, and healthcare professionals on the frontlines have worked hard to provide care under extremely difficult circumstances. Understandably, under this stress, many frontline healthcare workers have experienced symptoms of depression and burnout. We believe psychedelic medicine, when given with a supportive psychotherapy program like the EMBARK approach, may provide a promising treatment approach to bolster mental health,” said Dr. Alex Belser, Cybin’s Chief Clinical Officer.
“This clinical trial provides an opportunity to better understand the effectiveness of combining psilocybin and EMBARK. Learnings from this combination Phase 2 trial will inform the use of EMBARK in Cybin’s upcoming human studies using CYB003, a proprietary deuterated psilocybin analog that has the potential to reduce clinic times and dosing levels in half as well as potentially reduce side effects and adverse events,” said Doug Drysdale, Chief Executive Officer of Cybin.
About the Phase 2 trial
The Phase 2 clinical trial will enroll 30 frontline clinicians (physicians, nurse practitioners, physician assistants, nurses). Inclusion criteria include clinically significant symptoms of depression and anxiety (primary outcome) and existential distress (secondary outcome) following work exposure during the COVID pandemic. The trial will employ a randomized parallel design methodology using an active placebo. The primary outcome will be a comparison between the two groups in depression and anxiety as measured by the Montgomery Asberg Depression Rating Scale (MADRS) total at 4 weeks post dose session. The secondary outcome will be a comparison between the two groups in symptoms of existential distress measured by the Demoralization DS-ii at 4 weeks post dose session. A mediation analysis of self-reported mystical states (Mystical Experience Questionnaire-30 item (MEQ-30)) and psychological flexibility (Acceptance and Action Questionnaire II (AAQII)) on changes in the primary outcome (HADS) will be analyzed.
Additional assessments include measures of clinician burnout (Stanford Fulfillment Index), post-traumatic stress (PTSD Checklist for DSM-5 (PCL-5)) and a semi-structured interview to identify factors that positively and negatively influence the integration phase of psychedelic-assisted psychotherapy. The assessment will also characterize the process of psychological change and effects on work and home life.
Dr. Anthony Back is a recognized leader in the fields of palliative care and oncology. He is a board-certified physician at the University of Washington, Founding Co-director of the University of Washington Center for Excellence in Palliative Care, and a University of Washington professor of Oncology and Medicine. He is triple board certified in Hospice and Palliative Medicine, Medical Oncology and General Internal Medicine. He was the principal investigator for the National Cancer Institute-funded Oncotalk interventions, which enabled the founding of the nonprofit VitalTalk, co-wrote Mastering Communication with Seriously Ill Patients, produced the first iPhone app for clinician communication skills, and is a Contemplative Studies Fellow of the Mind and Life Institute. His clinical and research interests include patient-physician communication and quality of life in palliative care. Dr. Back earned his medical degree at Harvard Medical School.
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 the USA, UK 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 September 30, 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 Contact:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.com
Source: Cybin Inc.
Researchers discovered that DOI (a psychedelic that’s similar to LSD and mescaline) can reduce anxiety and increase neuroplasticity. Rats stopped showing anxious behaviours in response to fear triggers after a single dose!
