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Numinus to Host Extension of MAPS-Sponsored MDMA-Assisted Therapy for PTSD Trials

Numinus to Host Extension of MAPS-Sponsored MDMA-Assisted Therapy for PTSD Trials

Numinus will manage two new clinics in Montreal and Vancouver to host trials.

VANCOUVER, BC, Nov. 10, 2021 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a leader in psychedelics-focused mental healthcare, is pleased to announce that it has secured two new Canadian psychedelic clinics that will host the Canadian sites of the MAPS Public Benefit Corporation (MAPS PBC) study “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX).”

In addition to managing the two new clinics, which are fully compliant with Health Canada regulations and ready to provide MDMA-assisted therapy as part of the trial, Numinus will host the Montreal and Vancouver sites in MAPPUSX, which will continue to study the safety and efficacy of MDMA in treating severe PTSD, under the leadership of MAPS PBC as study organizer. Numinus will also financially support costs relating to therapists who deliver the therapeutic intervention in Numinus clinics during the trial.

“We are honored to host the Canadian sites of the MAPPUSX trial as we continue to examine the important findings around MDMA-assisted therapy for PTSD,” said Dr. Joe Flanders, VP, Psychology, Numinus and therapist for the Montreal site of the trial. “Our clinical and research teams are well positioned to implement MAPS’ research and, ultimately, to work with MAPS on the translation of research findings into mainstream clinical practice. We are excited about this study in both BC and Quebec and look forward to how the MAPPUSX study supports expanded collaboration in the future.”

To date, 25 Numinus-affiliated therapists have gone through MAPS’ training program for delivery of MDMA-assisted therapy and a number of these therapists will have roles in the trial. The trial will be open to eligible participants who were previously enrolled in the placebo arm of the parent study (MAPP1) or who were not able to receive treatment due to COVID-19 restrictions.

“We are happy to work with a trusted ally to quickly complete the extension trial at the Canadian sites” said Rick Doblin, Ph.D. the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS). “As we get closer to our goal of making MDMA-assisted therapy a reality, it is critical that we work with clinics who will advance making this treatment widely accessible in real-world settings.”

To accomplish this next step in the MAPPUSX study, Numinus has assumed the leases of two new clinics, the Vancouver and Montreal psychedelic-assisted psychotherapy clinics that were previously used to conduct MAPS PBC’s earlier study “A multi-site phase 3 study of MDMA-assisted psychotherapy for PTSD (MAPP1).” In that trial, 88% of participants experienced a clinically meaningful reduction in symptoms and 67% no longer qualified for a PTSD diagnosis. The highly statistically significant results and excellent safety record suggest MDMA-assisted therapy will be an effective treatment for severe, chronic PTSD

Payton Nyquvest, CEO, Numinus, added, “We are thrilled that our two new locations, which are purpose-developed for psychedelic-assisted therapy, regulatorily compliant and leading in industry standards, can be used to help advance this crucial work on psychedelic medicine. We look forward to deepening our collaboration with MAPS while expanding the resources and solutions available to those suffering from PTSD.”

Securing the Canadian sites will further allow Numinus to expand its clinical activities in Quebec and BC, including its ketamine-assisted psychotherapy program, which is available in both provinces.

NOTE
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by Health Canada or the U.S. Food and Drug Administration (FDA), does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.

About Numinus
Numinus Wellness (TSXV: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

About MAPS
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since its founding, MAPS has raised over $130 million for psychedelic and marijuana research and education and has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator. Learn more at maps.org

ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. Learn more at www.mapspublicbenefit.org

Forward-looking statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. 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. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

SOURCE Numinus Wellness Inc.

For further information: May Lee, Communications Manager, Numinus, may.lee@numinus.com; Betty Aldworth, Interim Communications Director, MAPS, maps.org/mediarequest or media@maps.org; For investor inquiries: Jamie Kokoska, VP, Investor Relations, Numinus, jamie.kokoska@numinus.com

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Entheon Biomedical Announces Recruitment Underway in EBIQ-101 Clinical Study

Entheon Biomedical Announces Recruitment Underway in EBIQ-101 Clinical Study

Entheon ID(TM) Clinical Study to Assess the Effect of Ketamine on Neurological Activity as Measured by EEG

Vancouver, British Columbia–(Newsfile Corp. – November 10, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company“), a biotechnology company focused on developing psychedelic medicines to treat addiction, announced today that recruitment has begun for the clinical research study with Heading Health LLC (“Heading Health”) as institution and Dr. Steve Levine, MD, as principal investigator to determine the electro-neurophysiologic effects of ketamine.

Entheon recently announced its sponsorship of the study, which will gather electroencephalogram (EEG) biomarker data and patient experience insight from individuals receiving ketamine therapy, and now confirms that enrolment has begun. The study population will be composed of participants who have been diagnosed with treatment-resistant Major Depressive Disorder and have been determined to have a medically appropriate indication for intramuscular ketamine treatment. The participants are also willing to wear an EEG headset which will measure brainwave patterns.

This study serves as the research foundation for two divisions of the company, Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, focused on the development of treatment algorithms through the analysis of patient data.

EBIQ-101, an Open Label Observational Study, will observe the EEG pattern of participants being treated with intramuscular ketamine. The data collected will be used to inform the understanding of brain activity changes in response to ketamine. In addition, genetic markers across participants will be compared, with data on impact of genetic markers and response to ketamine also being analyzed.

Based on the two hypotheses being tested, that the clinical response to drug treatment can be accurately assessed during ketamine administration, and EEG changes can predict long term response to drug treatment Entheon intends to develop a framework of understanding for characterizing the psychedelic drug state of patients and to research phenotypes associated with particular addictions and mental health disorders.

“The initiation of EBIQ-101 study is a landmark occasion for Entheon’s ID™ and Entheon IQ™ programs,” said Timothy Ko, Chief Executive Officer of Entheon. “We believe that personalized medicine is the future of psychedelic psychiatry, and that EEG and genetic-based biomarkers will add much needed layers of data insight which can be used to improve patient care.”

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

About Heading Health LLC

Founded in Austin, Texas, Heading Health delivers mental healthcare which is high quality, affordable and accessible. A comprehensive set of evidence-based, insurance covered therapeutics and technologies are available through Heading, including Spravato (esketamine), Transcranial magnetic stimulation (TMS), telepsychiatry and Intramuscular (IM) ketamine.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
joe@entheonbiomedical.com
https://entheonbiomedical.com/

For media inquiries, please contact Elizabeth Glassen of BlueSky Communications at:

BlueSky Communications
Elizabeth Glassen, Account Manager
Telephone: +1 (647) 309-0141
eglassen@blueskycommunications.com

Cautionary Note on Forward-Looking Information

This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to a strategic investment, the performance of such investment and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct.

Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, the design and commencement of the study of the electroneurophysiologic effects of ketamine, the effects of ketamine, obtaining regulatory approvals, subject enrollment, obtaining meaningful data, if at all, and the outcome of the study. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement.

Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release

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The results from the world’s biggest psilocybin trial are in!

COMPASS Pathways announces positive topline results from groundbreaking phase IIb trial of investigational COMP360 psilocybin therapy for treatment-resistant depression

COMPASS Pathways’ (CMPS) stock dropped nearly 30% after announcing mixed study findings and Q3 financial results on Monday.

The company conducted a trial on 233 patients to determine the best psilocybin dose for treatment-resistant depression (TRD).

All three groups showed improvements the day after receiving the dose. The group with the largest dose had the best results, with 36.7% of patients showing at least a 50% decrease in depression scores and 29.1% in remission at week 3. A quarter of the patients showed sustained improvements until week 12.

Unfortunately, 12 patients experienced serious adverse events such as suicidal ideation or self harm, but these behaviours are common in patients with TRD.

The company is preparing for a larger trial beginning next year.

COMPASS also announced that it lost $15.8 million or $0.38 per share in Q3, an improvement compared to its $1.30 loss per share in Q3 of last year.

PDF of article 1

PDF of article 2

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COMPASS Pathways announces positive topline results from groundbreaking phase IIb trial of investigational COMP360 psilocybin therapy for treatment-resistant depression

COMPASS Pathways announces positive topline results from groundbreaking phase IIb trial of investigational COMP360 psilocybin therapy for treatment-resistant depression

Largest randomised, controlled, double-blind psilocybin therapy study ever completed shows rapid and sustained response for patients receiving a single dose of COMP360 psilocybin with psychological support

COMPASS management team to host an investor conference call today at 1.00pm UK (8.00am ET)

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced that its groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression has achieved its primary endpoint for the highest dose, with a 25mg dose of COMP360 demonstrating a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response*.

In the randomised, controlled, double-blind trial, a single dose of investigational COMP360 psilocybin was given to 233 patients in conjunction with psychological support from specially trained therapists. All patients discontinued antidepressants prior to participation. The trial was powered to compare two active doses of COMP360, 25mg and 10mg, against a comparator 1mg dose. The 25mg group vs the 1mg group showed a -6.6 difference on the MADRS* depression scale at week 3 (p<0.001). The 25mg group demonstrated statistical significance on the MADRS efficacy endpoint on the day after the COMP360 psilocybin administration (p=0.002). The 10mg vs 1mg dose did not show a statistically significant difference at week 3. The MADRS was assessed by independent raters who were remote from the trial site, and blind to intervention and study design, effectively creating a triple blind. At least twice the number of patients in the 25mg group showed response and remission* at week 3 and week 12, compared with the 1mg group. The protocol-defined sustained response* up to week 12 was double, with 20.3% of patients in the 25mg group vs 10.1% in the 1mg group. Using a definition of sustained response* that is consistent with other TRD studies, the difference was more than double, with 24.1% of patients in the 25mg group vs 10.1% in the 1mg group. COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) being mild or moderate in severity. 179 patients reported at least one TEAE; the most common TEAEs across treatment groups (>10% overall incidence) were headache, nausea, fatigue and insomnia. There were 12 patients who reported treatment-emergent serious adverse events (TESAEs). These TESAEs included suicidal behaviour, intentional self-injury, and suicidal ideation, which are regularly observed in a treatment-resistant depression patient population, and which occurred more frequently in the 25mg group than in the 10mg or 1 mg groups. Overall, 209 patients completed the study; there were five withdrawals from the 25mg group, nine from the 10mg, and 10 from the 1mg.

This randomised, controlled, multicentre, double-blind phase IIb trial is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. 94% of the patients had no prior experience with psilocybin. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

Depression that isn’t helped after two or more adequate antidepressive treatments is referred to as treatment-resistant depression (TRD)1,2. More than 100 million people worldwide are affected by TRD1,2, and as many as 30% of these attempt suicide at least once during their lifetime3,4. The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designation for its COMP360 psilocybin therapy for TRD.

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said: “No one is untouched by the mental health crisis – everyone has a story. We urgently need options for people who are not helped by existing therapies. We set out to explore the safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression, through a rigorous and large-scale trial, and to find an appropriate dose to take to the next stage. I am delighted that we have succeeded in doing this. We have demonstrated our ability to execute an innovative, multicentre, multinational clinical trial programme – and in the midst of a global pandemic. Our work follows the efforts and achievements of so many researchers before us, and we are grateful to all of them and for the opportunity to work with the mental health care community to transform patient experience and patient outcomes. With our world-leading psychedelic research over the last few years, we have now created a unique and extensive data lake; this provides an unprecedented opportunity to further evaluate and optimise psilocybin therapy for patients suffering with serious mental health illness. With these compelling data, we will urgently progress our clinical development programme and move closer to making this therapy accessible to patients in need, if approved.”

Key findings:

  • COMP360 25mg vs 1mg: a difference of -6.6 points in change from baseline in MADRS total scores at week 3 (p<0.001), with a statistically significant difference seen from day 2 up to week 6
  • COMP360 10mg vs 1mg: a non-statistically significant numerical treatment difference of -2.5 points at week 3 (p=0.184)
  • At least double the number of MADRS responders, remitters, and sustained responders with 25mg vs 1mg; rapid response and remission from day 2 to week 3
    • 36.7% (29 patients) in 25mg group showed response at week 3, compared with 17.7% (14 patients) in 1mg group
    • 29.1% (23 patients) in 25mg group were in remission at week 3, compared with 7.6% (6 patients) in 1mg group
    • 24.1% (19 patients) in 25mg group were sustained responders at week 12, compared with 10.1% (8 patients) in 1mg group
  • COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) mild or moderate in severity
  • Treatment-emergent adverse event (TEAE) incidence
    • 5% (66 patients) in 25mg group
    • 7% (56 patients) in 10 mg group
    • 2% (57 patients) in 1 mg group
  • Treatment-emergency serious adverse event (TESAE) incidence
    • 3% (5 patients) in 25mg group
    • 0% (6 patients) in 10 mg group
    • 3% (1 patient) in 1mg group

David J Hellerstein MD, a Principal Investigator on the trial and Professor of Clinical Psychiatry at the Columbia University Irving Medical Center, said: “Treatment-resistant depression is a common and devastating condition, affecting tens of millions of people, with few effective treatments. This is the largest modern study of a psychedelic drug, combined with psychological support, enrolling over 200 people with TRD. In this groundbreaking study, a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks. Remission rates appear to be higher than seen in traditional medication studies. We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder. These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”

Michael Pollock, CEO at the Depression and Bipolar Support Alliance (DBSA), said: “Many people suffering with severe forms of depression find that existing treatments don’t work for them. We support any attempt to investigate alternative therapies. The approach of cycling through drugs that aren’t working is inadequate for anyone who is living with a mental health condition and disheartening for the family members and healthcare professionals who care for them. The results seen from this study are an early indicator of hope for those who are desperately in need of help.”

Robin Carhart-Harris PhD, Director of the Psychedelics Division at the Weill Institute for Neurosciences at the University of California San Francisco, and Ralph Metzner Distinguished Professor of Neurology, Psychiatry and Behavioral Sciences, said: “This is an important and exciting moment for the mental health care community. It builds upon more than two decades of research into the viability of psychedelic compounds to treat mental health conditions and demonstrates the potential it has in helping people living with treatment-resistant depression. It’s encouraging to see how far this field has progressed in the last 20 years and I look forward to further research.”

In addition to this topline data, COMPASS is conducting comprehensive secondary analyses which are expected to further inform the clinical development programme for COMP360 psilocybin therapy. In the meantime, this promising topline data will be shared in an expeditious manner with regulators as part of an ongoing dialogue.

Conference call

The COMPASS management team will host a conference call at 1:00pm UK (8.00am ET) on 9 November. The call can be accessed by dialing (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 34908054.

The call will also be webcast on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.

About treatment-resistant depression (TRD)

More than 320 million people globally suffer with major depressive disorder (MDD)5, the leading cause of disability worldwide and one of the fastest growing mental health illnesses6. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with treatment-resistant depression (TRD)7. TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients8.

About the COMP360 psilocybin therapy phase IIb study

The phase IIb study was a dose-finding study, assessing the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; assessments were made by an independent, blinded rater. The primary endpoint is the change in the MADRS total score from baseline to week 3.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. We are headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS’s business strategy and goals, the future accessibility of COMP360 psilocybin therapy, COMPASS’s ability to continue to advance its research, including COMP360, COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS’s ability to advance new psychedelic compounds in other areas of unmet mental health need. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

 

 

 

*Notes: MADRS = Montgomery-Åsberg Depression Rating Scale; response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10; protocol-defined sustained response = patients meeting the MADRS response criteria from week 3 until week 12; sustained response = patients meeting the MADRS response criteria at week 3 and at week 12, and at least at one visit out of week 6 and week 9

  1. WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf
  2. Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388
  3. Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. Journal of Affective Disorders. 2018;235:362-367
  4. Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiology and Psychiatric Sciences. 2020;29:e63
  5. WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]
  6. WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]
  7. Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.
  8. Gang L, Fife D, Wong G, Sheehan JJ, et al. All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population. Annuals of General Psychiatry. 2019; 18:23
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Awakn Life Sciences Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry

Awakn Life Sciences Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry

Worlds’s First Controlled Study To Investigate Ketamine-Assisted Psychotherapy

TORONTO, CANADA, November 4, 2021 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, announced today that the ‘Ketamine in the Reduction of Alcoholic Relapse’ (KARE) psychotherapy intervention study, which was the first controlled study in the world to investigate ketamine-assisted psychotherapy, will be published in the American Journal of Psychiatry later this year. The study was conducted by University of Exeter (UoE) and led by Prof. Celia Morgan, Professor of Psychopharmacology at UoE and Awakn’s Head of Ketamine-assisted psychotherapy for addiction. Awkan has acquired the rights to this research.

The findings, which will be shared in detail in the journal, are a very exciting step forward in the treatment of alcohol use disorder and for the wider psychedelic industry in general. The phase II a/b trial had four groups, ketamine with and without therapy, and placebo administered with and without therapy.

Professor Morgan commented “We are delighted that the findings are to be published in the American Journal of Psychiatry. This new approach looks set to revolutionise the treatment of alcohol use disorder. We are excited to partner with Awakn for the next steps in the journey of ketamine-assisted therapy into a licensed treatment for this group of patients with limited treatment options.”

With ketamine already a licenced medicine, the phase II a/b results allow Awakn to deliver the KARE treatment in its clinics in the UK and Europe immediately and through its licencing partnerships outside of these territories. The University of Exeter and Awakn are investigating how best to move this research forward to a pivotal phase III trial, which ultimately would allow it to be delivered ‘on label’, meaning it could be adopted by public health systems and covered by insurers.

Following the study, Dr. Morgan’s research team also interviewed participants in the trial and published an analysis of their experiences in the journal Frontiers in Psychiatry entitled, “This Is Something That Changed My Life: A Qualitative Study of Patients’ Experiences.” A brief selection of quotes from the paper below, show the life-changing effect the treatment had on them and crucially how it changed their relationship with alcohol.

It helped family wise, relationship wise, in every, every single avenue of my life, It’s changed it.

I wouldn’t be here now if it wasn’t for it. I can definitely say that.

I feel I have much less desire to drink now than I used to. And I think what it is, I actually, I think I enjoy it less now”

“I think before the trial all my life was sort of focused around alcohol. I was either drinking it at home or selling it to students or working in an event where there was alcohol, the alcohol was a focus of it. So it was sort of everything and then afterwards, it just sort of stopped.

Chief Executive Officer of Awakn, Anthony Tennyson commented; “This is a very exciting moment for ketamine-assisted psychotherapy. For so many people who are suffering from alcohol addiction, for whom the current treatments just aren’t working, a successful phase II a/b trial and a unified ambition to progress this forward to a pivotal trial, gives real hope to those seeking a better and healthier future.”

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company with clinical operations, developing and delivering psychedelic therapeutics (medicines and therapies) to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will deliver these evidence backed psychedelic therapies in clinics in the UK and Europe and through licensing partnerships globally.

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:
America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com

Rest of World:
ROAD Communications
Paul Jarman / Anna Ramsey

Awakn@roadcommunications.co.uk

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Blackhawk Growth’s MindBio Therapeutics Looks to Expand Microdosing Clinical Trials

Blackhawk Growth’s MindBio Therapeutics Looks to Expand Microdosing Clinical Trials

Vancouver, British Columbia – November 01, 2021 – Blackhawk Growth Corp. (CSE:BLR; Frankfurt:0JJ) (the “Corporation” or “Blackhawk”), is pleased to announce that MindBio Therapeutics Pty Ltd (“MindBio”) is working to expand its microdosing clinical trials. MindBio is a multi-disciplinary company pioneering new treatments for mental health conditions using psychedelic medicines, technology assisted mental health interventions and psychedelic assisted psychotherapies.

MindBio is currently undertaking a world’s first clinical trial of its kind. In its phase 1 clinical trial microdosing LSD (Lysergic Acid Diethylamide), MindBio is microdosing LSD to 80 healthy participants who take the drug at home in the same way that they would take any other medication. MindBio will lead phase 2 clinical trials microdosing LSD to patients with major depressive disorder and in patients with late-stage cancer – with those trials set to begin in mid-2022.

Pre-clinical research has demonstrated that psychedelic substances, including LSD, psilocybin, ayahuasca and DMT, affect neuroplasticity after acute and chronic administration. The data generated from in-vitro studies conducted by the Beckley Foundation1 demonstrated neuroplasticity by the presence of Brain Derived Neurotropic Factor (BDNF) in blood plasma. Studies conducted at the University of California, Davis2 have also shown that microdosing psychedelics such as LSD and psilocybin promote increased neurite growth, spine density and synaptogenesis.

MindBio is currently assessing natural psilocybin and potential analogs as a candidate for phase 1 microdosing clinical trials. The company can scale microdosing clinical trials to other substances quickly and cost effectively. MindBio is seeking advice on designing the clinical trial protocols given the potential for psilocybin to treat a number of mental health conditions such as major depressive disorder, PTSD and anxiety.

In addition, Blackhawk’s CEO, Frederick Pels, will be contributing to the psychedelics microdosing discussions at the upcoming Wonderland convention in Miami, where MindBio is a Gold Sponsor. The event is being promoted by conference organiser Microdose as “the biggest psychedelics business event, ever”.

1.https://www.beckleyfoundation.org/2018/06/13/psychedelics-promote-neural-plasticity/

2.https://www.cell.com/cell-reports/fulltext/S2211-1247(18)30755-1

About Blackhawk Growth

Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow and is growing at an exceeding pace.

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to transaction and future operations of MindBio Therapeutics Pty Ltd. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

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First-of-its-kind study on severe anxiety

World-first psilocybin clinical trial in the treatment of Generalised Anxiety Disorder receives ethics approval

This Australian university just got the go-ahead to conduct a first-of-its-kind study!

Yesterday, Monash University received ethics approval for a triple-blinded, active-placebo-controlled study that will investigate psilocybin-assisted psychotherapy as a treatment for severe Generalized Anxiety Disorder (GAD).

Researchers are looking to recruit 72 patients for the study, which will be conducted in partnership with Incannex Healthcare Ltd (IHL).

The therapists facilitating the study will have the option to undergo their own psilocybin session to better understand what the patients will experience.

PDF of article

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Largest psilocybin study continues to grow

COMPASS Pathways plc announces financial results and business highlights for the second quarter 2021

The world’s largest psilocybin therapy study on depression is approaching completion, and it’s even bigger than expected.

Compass Pathways (CMPS) announced that it’s close to completing its phase 2b trial on treatment-resistant depression, and expects to report the findings by the end of this year. So far, 233 patients have received COMP360 psilocybin therapy, exceeding the target of 216. The company also announced its Q2 financial highlights including $316.3 million in cash and equivalents as of June 30.

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The safest recreational drug becomes even safer

Mindset Pharma Announces Additional Preclinical Results Suggesting Superior Efficacy and Improved Safety in Head-to-Head Comparison to Psilocybin for its First Lead Clinical Candidate, MSP-1014

Magic mushrooms are the safest recreational drug according to a recent study, but Mindset Pharma (MSET) is working to make them even safer.

The company found that its patent-pending psychedelic compound, MSP-1014, may be more effective, safer, and more scalable than psilocybin. Researchers discovered that MSP-1014 more than doubled the head twitch responses in mice, an indicator of serotonin 5-HT2A receptor activity, which is tied to psychedelic experiences. MSP-1014 did not cause body temperature to drop, which was seen with psilocybin.

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Avoid daily antidepressants with a monthly trip

Single Dose of Psychedelic Compound Psilocybin Can Remodel Connections in the Brain

It’s clear that psychedelics are helpful in treating depression, but have you ever wondered why they work so well?

When someone suffers from depression or chronic stress, they typically have a reduction in neural connections, but psychedelics might be able to reverse this. A study at Yale just revealed that one dose of psilocybin can increase these neuronal connections by 10%. The dose also increased the density of dendritic spines (those little spikey things on nerve cells), making the connections stronger. About a third of the new connections remained intact after 34 days.

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PDF of study