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MYND Life Sciences Provides Update on Depression Gene Modulation Pathway Patent Application

MYND Life Sciences Provides Update on Depression Gene Modulation Pathway Patent Application

VANCOUVER, BC, Dec. 15, 2021 /CNW/ – MYND Life Sciences Inc. (“MYND” or the “Company“) (CSE: MYND) (OTC: MYNDF) is pleased to announce it has completed the National Phase filing of its Patent Cooperation Treaty (PCT) patent application, following on previously submitted provisional patent applications that describe:  “A Method of Immune Modulation by Modulating a Specific Gene.”

“MYND’s is profoundly different than the majority of the Psychedelics’ sector. We are seeking intellectual property protection through the pursuit of patents by validation of our Intellectual Property through research and development,” stated Dr. Lyle Oberg, MD, CEO of MYND. “As this sector grows and matures and as MYND develops our novel drug development pipeline, the creation of a solid intellectual property portfolio is the key to creating lasting shareholder value. MYND’s ability to obtain patent protection will allow us to move towards the filing of Innovative New Drug (IND) application and approval status.”

According to the World Health Organization, over 300,000,000 people globally suffer from depression and other psychiatric disorders. Major Depressive Disorder and Treatment Resistant Depression have a greater than 50% chance of relapse using conventional methods of treatment. Traditional treatments focus solely on symptom suppression, not the root cause. Covid-19 has accelerated the ongoing mental health crisis around the world. In a June 2020 CDC survey, 31% of US respondents reported symptoms of anxiety or depression, 13% started/increased substance use, 26% reported stress-related symptoms, 11% reported serious thoughts of suicide in preceding 30 days. These numbers are double pre-pandemic levels.

The Patent Cooperation Treaty (PCT) is an international treaty with more than 150 Contracting States. The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single “international” patent application instead of filing several separate national or regional patent applications. The granting of patents remains under the control of the national or regional patent offices in what is called the “national phase”. https://www.uspto.gov/patents/basics/international-protection/patent-cooperation-treaty

MYND MARKETING AND INVESTOR RELATIONS AGREEMENTS

MYND has retained Hybrid Financial Ltd. (“Hybrid”) to provide marketing services to the Company. Hybrid has been engaged to heighten market and brand awareness for MYND and to broaden it’s reach within the biotech drug research and development investment community. Hybrid has been engaged for a monthly fee of $22,500 by the Company for an initial period of twelve months, commencing November 16, 2021.

ABOUT MYND LIFE SCIENCES INC.

MYND Life Sciences Inc. is a medical biotech drug research and development company focused on neuro-pharmaceutical and novel psilocybin drug development, diagnostics and vaccines. The Company is advancing pharmaceuticals through rigorous science and clinical trials, while diligently patenting and safeguarding its intellectual property. For more information and to subscribe to MYND’s mailing list, please visit https://myndsciences.com/contact/.

CONTACT INFORMATION
Dr. Lyle Oberg, MD, CEO
Email: ir@myndsciences.com 
Web: www.myndsciences.com

Forward-Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of MYND to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this release.  

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

None of the securities issued in connection with the Offering will be registered under the United States Securities Act of 1933, as amended (the “1933 Act”), and none of them may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the 1933 Act. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state where such offer, solicitation, or sale would be unlawful.

SOURCE Mynd Life Sciences Inc.

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A better solution for cancer patients

B.C.’s functional and psychedelic mushroom industry is having a shroom boom

Antidepressants are often ineffective and can even interfere with cancer treatment drugs.

“Psychedelics are proving to not conflict with the cancer drug and are more effective than normal antidepressants generally,” according Frank Lane, director of Albert Labs. 

That’s why the BC-based company wants to bring a psilocybin treatment for cancer patients to European markets.

Albert Labs is expected to begin trading on the CSE early next year under the ticker ’ABRT’.

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Braxia Scientific Achieves Milestone as Landmark Psilocybin Clinical Trial Commences, Participants Receive First Doses of Psilocybin

Braxia Scientific Achieves Milestone as Landmark Psilocybin Clinical Trial Commences, Participants Receive First Doses of Psilocybin

  • Patients receive first dose in first-ever Health Canada-approved, multi-dose psilocybin clinical trial conducted at Braxia Scientific’s subsidiary CRTCE clinic
  • Trial establishes psilocybin treatment framework for patients with TRD and opens new pathway for patients to access psychedelic treatment

TORONTO, ONTARIO December 14th, 2021 – Braxia Scientific Corp. (“Braxia”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 496), a medical research company with clinics providing innovative psychedelic treatments for persons with depression and related disorders, has reached a milestone as the first Health Canada-approved multiple-dose psilocybin clinical trial which commenced with first patients dosed in November 2021. The trial, which is being sponsored by the Brain and Cognition Discovery Foundation, is being conducted at the Canadian Rapid Treatment Center of Excellence (CRTCE), a wholly owned Braxia subsidiary, and includes adults with treatment-resistant depression (TRD) as part of bipolar or unipolar disorder, who have not benefited from multiple conventional treatments. This study is the only Health-Canada approved psilocybin trial in Canada that is actively recruiting participants at this time.

Of the more than 300 million people suffering with depression worldwide, it is estimated that up to two thirds of affected people receiving treatment will inadequately respond to currently approved treatments, making patients with TRD a very large population that disproportionately dominates the majority of mental health services.

“This is a historically significant occasion for our patients, for Braxia, and for other organizations that endeavour to discover and develop innovative rapid-acting psychedelic treatments for the mental health sector,” said Braxia Scientific CEO Dr. Roger McIntyre.

“For patients who have undergone at least two – and possibly dozens of – unsuccessful conventional treatments for their depression, this remedy offers a potential and innovative treatment avenue for adults with TRD.”

“For Braxia Scientific, it marks two very important milestones. First, this trial establishes a proprietary framework and positions our platform among the leading groups that endeavour to research and develop new psychedelic treatments for TRD. Second, our proprietary data from this landmark trial will enable us to continue our work developing potential new chemical entities in the future, while providing patients with TRD immediate access to new treatment.”

Dr. Joshua Rosenblat, Braxia’s Chief Medical and Scientific Officer and the Principal Investigator (PI) of the trial, added, “Outside of rare exemptions for a very small number of patients with terminal medical illnesses, the only way to legally access psilocybin treatment in Canada is through Health Canada-approved clinical trials. As we have the country’s only open trial (e.g., only one actively recruiting, enrolling and treating participants with psilocybin), the CRTCE is currently the only place in Canada that can legally provide psilocybin for depression in the absence of any comorbid medical condition.”

Building on management’s extensive clinical and research expertise, the Company has expanded the necessary infrastructure to provide novel interventions that include ketamine, psilocybin and other potential future psychedelics that become available.

More specifically, the Company infrastructure has:

  • Established access to a high-quality source of psilocybin that meets all regulatory requirements for human use in clinical research
  • Received more than 150 referrals to date for psilocybin-assisted therapy for treatment resistant depression at our clinic in the first six weeks of opening recruitment
  • Received Health Canada and Research Ethics approval for protocols to collect treatment outcome data to allow for further optimization of psilocybin treatment protocols and development of best practice guidelines
  • Trained medical and research staff as part of Braxia Institute to provide psilocybin-assisted therapy with high quality safety monitoring. This program includes twenty (20) therapists licensed to practice in Ontario with specialized training in psilocybin-assisted therapy. All therapists were trained by the Braxia Institute and are serving as study therapists for the active psilocybin clinical trial.
  • Developed physical space to safely provide psilocybin treatment with a comfortable living room-like environment with appropriate medical and psychological monitoring and protocols

“This tremendous infrastructure enables Braxia Scientific to provide psilocybin-assisted therapy today, as part of the current clinical trial, and importantly, if psilocybin is approved in the future for use outside of clinical trials, Braxia Scientific is positioned to immediately provide access to psilocybin-assisted therapy treatment for eligible patients,” commented Dr. Rosenblat.

The trial will also provide Braxia Scientific a chance to evaluate the psilocybin-assisted therapy training program launched earlier this year. Upon completion of the psilocybin study, this program, run by the Braxia Institute, the Company’s training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy, is set to graduate its first cohort of medical professionals, a multidisciplinary group of 20 therapists from diverse psychiatry and psychotherapy backgrounds.

About Braxia Scientific Corp.

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based mental disorders such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD

“Dr. Roger S. McIntyre”

Dr. Roger S. McIntyre
Chairman & CEO

FOR FURTHER INFORMATION PLEASE CONTACT:
Braxia Scientific Corp.
Tel: 416-762-2138
Email: info@braxiascientific.com
Website: www.braxiascientific.com

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement


This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements.”

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements.

Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

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The findings from COMPASS’s depression study keep coming!

COMPASS Pathways announces positive outcome of 25mg COMP360 psilocybin therapy as adjunct to SSRI antidepressants in open-label treatment-resistant depression study

COMPASS Pathways’ (CMPS) announced that patients taking SSRI antidepressants in conjunction with psilocybin therapy had similar outcomes and fewer side effects compared to those who withdrew from SSRIs before the study.

Five patients who withdrew from SSRIs had serious adverse effects, such as suicidal ideation, when given the largest dose. None of the patients on SSRIs had this experience. 

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Cybin Confirms Scientific Advice Meeting with UK Medical and Healthcare Products Regulatory Agency for Lead Candidate CYB003 for the Treatment of Major Depressive Disorder and Alcohol Use Disorder

Cybin Confirms Scientific Advice Meeting with UK Medical and Healthcare Products Regulatory Agency for Lead Candidate CYB003 for the Treatment of Major Depressive Disorder and Alcohol Use Disorder

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™” is pleased to announce that it has confirmed a scientific advice meeting with the UK Medical and Healthcare Products Regulatory Agency (“MHRA”) for the first quarter of calendar year 2022. This program milestone brings the Company closer toward advancing its lead investigational candidate CYB003 into clinical development for the treatment of major depressive disorder (“MDD”) and alcohol use disorder (“AUD”).

“Encouraged by positive preclinical findings that demonstrated the advantages of our novel deuterated psilocybin analog over oral psilocybin for the treatment of mental health, we are moving rapidly to progress CYB003 toward clinical development. We are looking forward to engaging with the MHRA to determine next steps for our clinical development path evaluating CYB003 for the treatment of MDD and AUD in the UK,” said Doug Drysdale, Chief Executive Officer of Cybin.

“CYB003 was designed to address the shortcomings of existing treatments, while retaining the therapeutic benefits of oral psilocybin. We believe that CYB003 has the potential to achieve better patient outcomes, including less variability, faster onset of action, shorter duration of effect, and improved brain penetration. As a society, we need to prioritize the treatment of mental health, and Cybin is committed to taking these next important steps toward progressing psychedelics to therapeutics,” concluded Drysdale.

On November 8, 2021, the Company reported preclinical data for CYB003 demonstrating:

  • a 50% reduction in variability compared to oral psilocybin; indicates potential for more accurate dosing in patients with MDD and AUD;
  • a 50% reduction in dose compared to oral psilocybin; indicates potential to maintain equivalent efficacy while reducing side effects, such as nausea, in patients with MDD and AUD;
  • a 50% shorter time to onset when compared to oral psilocybin; indicates potential for shorter duration of treatment, lower inter-subject variability, better therapeutic control and safety, leading to a better patient experience, with lower cost and scalability; and
  • nearly double brain penetration when compared to oral psilocybin; indicates potential for a less variable treatment response, a lower dose therapeutic effect, and reduced patient side effects.

The Company plans to file a clinical trial application with the MHRA in the second quarter of calendar year 2022.

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 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 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:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

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How to cure depression in two hours

GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression

GH Research (GHRS) discovered that the most powerful psychedelic, 5-MeO-DMT (aka toad venom), is highly effective at curing treatment-resistant depression.

Out of eight patients, seven were in remission from depression just one day after receiving the company’s proprietary formulation, and five of those were in remission in as little as two hours. 

All eight patients showed improved depression scores, with an average reduction of 76%. 

GH Research Logo

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GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression

GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression

  • Primary endpoint met in Phase 2 part of clinical trial for GH001 in TRD
    • 7 of 8 patients (87.5%) were in remission (MADRS ≤10) at day 7 after dosing (p<0.0001)
  • Secondary endpoints met
    • Mean change from baseline in MADRS at day 7 after dosing was -24.4 points (-76%) (p<0.0001)
    • GH001 was well tolerated and no serious adverse events were reported
  • In addition, we announce positive preliminary safety results from a Phase 1 clinical pharmacology trial of GH001 in 46 healthy volunteers with 30-day follow-up supporting the safety profile of GH001 beyond day 7.

DUBLIN, Ireland, Dec. 06, 2021 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported the successful outcome of the Phase 2 part of a Phase 1/2 clinical trial of GH001, an inhalable 5-MeO-DMT product candidate, in patients with treatment-resistant depression (TRD) (GH001-TRD-102).

The primary endpoint of the Phase 2 part of the trial was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001). According to FDA Guidance for Industry, a 7-day endpoint is an appropriate primary efficacy endpoint for rapid-acting antidepressants.

The Phase 2 part of the clinical trial recruited 8 patients. The median age was 34 years. The median baseline severity of depression by MADRS was 32.

Patients followed a proprietary GH001 individualized dosing regimen administered on a single day with up to three increasing doses of GH001 (6 mg, 12 mg and 18 mg). The second and third doses were only administered in the event that the patient did not achieve a peak experience1 (PE) at the previously administered dose. Based on this trial design, 6 patients received 6 mg and 12 mg doses of GH001 and 2 patients received 6 mg, 12 mg and 18 mg doses of GH001. 7 patients were able to achieve a PE at their final dose, and at this final dose the mean PE total score was 90.4.

Of the 7 patients who had a remission at day 7, all were in remission beginning on day 1, with 5 in remission as early as 2 hours after dosing. The single patient who did not achieve a remission at day 7, also improved on day 7 versus baseline. 6 of the 7 patients in remission had achieved a PE at their final dose. The mean MADRS change from baseline for all 8 patients at day 7 was -24.4 points (-76%) (p<0.0001).

Compared with the single dose results in the previously reported Phase 1 part of the trial (12 mg, n=4; 18 mg, n=4), the proprietary GH001 individualized dosing regimen increased the rate of MADRS remission at day 7, increased the mean MADRS absolute change from baseline at day 7, increased the rate of PE, and increased the mean PE score achieved.

In accordance with the trial protocol, a study safety group (SSG) was established, including external experts, to evaluate the safety data for the clinical trial. All patients completed all planned visits. No serious adverse events (SAE) were reported. 7 of 8 patients (87.5%) experienced at least one adverse drug reaction (ADR), all of which were mild (81%) or moderate (19%) in intensity, and all of which resolved spontaneously. The ADRs reported were: headache, sensory disturbance (each in 3 patients), anxiety, flashback, nausea (each in 2 patients), muscle discomfort, abdominal discomfort, paresthesia, depressive symptom (each in 1 patient). Based on the full safety results of the trial, the SSG concluded that no unexpected or severe adverse effects and no clinically significant changes were observed in any of the safety laboratory analyses, vital signs, psychiatric safety assessments or measures of cognitive function and that no signal for suicidal ideation or behavior was observed.

Safety Results from Phase 1 Clinical Pharmacology Trial in Healthy Volunteers

In addition, we also reported positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103).

This trial enrolled 46 healthy volunteers with 30-day safety follow-up. The trial investigated three different single doses of GH001 in a double-blind, placebo-controlled design (6 mg (n=8), 12 mg (n=8), 18 mg (n=8), placebo (n=2 in each dose group)) and a proprietary GH001 individualized dosing regimen with intra-subject dose escalation within a single day in an open-label, non-randomized design in two groups with two different intervals between doses (1 hour (n=8), 2 hours (n=8)).

All subjects completed all planned visits. No SAEs were reported. 11 of 24 subjects (45.8%) who received GH001 in the single-dose part and 0 of 6 subjects (0%) who received placebo in the single-dose part experienced at least one ADR. In the multiple-dose part, 7 of 16 subjects (43.8%) who received GH001 experienced at least one ADR. All ADRs were mild and all ADRs resolved spontaneously. In the single-dose part, the ADRs reported were: headache (in four participants), tachycardia, crying (each in two participants), chest discomfort, dizziness, dry mouth, dyskinesia, fatigue, hypoesthesia oral, retching, somnolence, tremor (each in one participant). In the multiple dose part, the ADRs reported were: fatigue (in three participants), headache (in two participants), abnormal dreams, paresthesia oral, crying, tension (each in one participant). No clinically relevant changes were observed for vital parameters, peak expiratory flow rate, safety laboratory analyses, ECG and psychiatric safety assessments.

The preliminary results of this 30-day trial support the safety profile of GH001 single doses and the proprietary GH001 individualized dosing regimen with intra-subject dose escalation within a single day. Final source data verification, the pharmacokinetic analyses and analyses of various secondary endpoints are still ongoing. The full results from this trial are intended to support the selection of the optimal dosing interval for the individualized dosing regimen in future studies of GH001.

1The occurrence of peak experiences (PE) is assessed using a proprietary visual analogue scale (PE scale), which averages answers scored by the patient from 0 to 100 for three parameters of the experience: intensity, feelings of loss of control and profoundness. A PE is defined as a total score of at least 75 on this scale.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC’s initial focus is on developing its novel and proprietary 5-MeO-DMT therapies for the treatment of patients with treatment-resistant depression (TRD).

About GH001

Our lead product candidate, GH001, is formulated for 5-MeO-DMT administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity, where 87.5% of patients with TRD were brought into an ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has potential to change the way TRD is treated today. Across the GH001 program, no serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized dosing regimen.

Forward-Looking Statements

This press release contains statements that are, or may deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations
Julie Ryan
GH Research PLC
investors@ghres.com

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Participate in psychedelic research from your phone!

World’s Largest Mobile Microdosing Study Published in Nature Scientific Reports

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!

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Psychedelics → spirituality → emotional regulation → happiness

Study suggests psychedelics promote positive mental health through increased spirituality and emotion regulation

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.

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