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PharmaTher Announces Positive Results from Study For Ketamine Microneedle Patch

PharmaTher Announces Positive Results from Study For Ketamine Microneedle Patch

Successfully delivered ketamine and KETABET™ (ketamine and betaine) via microneedle patch, unlocking the potential for desired dosage forms and pharmacokinetic profiles

Pursuing Phase 2 clinical studies in treatment-resistant depression and pain indications in Q4-2022

TORONTO, June 29, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that it has successfully completed its research study evaluating the Company’s patented hydrogel-forming microneedle patch, PHARMAPATCH™, to deliver ketamine and KETABET™ (ketamine and betaine anhydrous), which aims to prevent the potential side effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, neurological disorders, and chronic pain.

PHARMAPATCH™ has been shown to successfully deliver esketamine, the S(+) enantiomer of ketamine, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format. Research results were published in a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery”1.

The aim of the research program led by Prof Ryan Donnelly at Queens University Belfast (“QUB”) was to develop and characterize PHARMAPATCH™ for the transdermal delivery of ketamine and KETABET™ in a sustained manner and finalize production scale-up processes for clinical studies. Characterization of drug recovery and stability before drug permeation from films via hydrogel-forming microneedle array patches (“MAP”) was assessed in vitro using the Franz cell apparatus. Based on the findings from in vitro permeation investigations, lead candidate MAP formulations were selected and brought forward for in vivo testing using Sprague-Dawley rats to assess the ability to achieve sustained plasma concentrations of ketamine and betaine within the therapeutic range for potential antidepressant therapy over the course of 48 hours.

PHARMAPATCH™ is an alternative platform that allows ketamine to be delivered transdermally in a sustained and de-risked manner. The results from this study represent the first time that multiple formulations of PHARMAPATCH™ for the delivery of ketamine and betaine have been developed, characterized and tested in an animal model. Extensive characterisation of each drug-containing polymeric film and hydrogel-forming MAP combination in terms of swelling capacity, insertion capabilities, drug recovery, stability, and ultimately in vitro drug permeation using the Franz cell apparatus allowed the selection of the most promising candidate formulations for in vivo testing. Hydrogel-forming MAP-mediated delivery of ketamine and betaine were compared with intramuscular injection and orally administered solution, respectively. At regular time intervals during the 48-hour rat study, blood sample results demonstrated that PHARMAPATCH™ was able to deliver plasma levels of ketamine (between 70-200 ng/mL) in a controlled manner throughout the study.

The findings of this work support PHARMAPATCH™ as a promising drug delivery platform through which effective, de-risked, and safe ketamine therapies can be delivered. Considering the high degree of flexibility possessed by this delivery system in terms of formulation, the potential for effective treatment regimens extending beyond 48 hours could be developed through further alterations in surface area, application time, and drug loading of these polymeric patches. 

The Company is preparing for a planned Phase 2 clinical study to allow for ketamine and KETABET™ microneedle patch evaluation in treatment-resistant depression and chronic pain under the FDA 505(b)(2) regulatory pathway. The Company is manufacturing its ketamine microneedle patches at LTS LOHMANN Therapie-Systeme AG for upcoming GLP pre-clinical pig studies to demonstrate the delivery, dosing and safety profile of ketamine in a comparable animal model to support regulatory filings to conduct human clinical studies in Q4-2022. In addition, scale up of the manufacturing process to support GMP and commercial production is currently underway.

About PHARMAPATCH™    

Microneedle-enhanced intradermal delivery is an elegant, efficient and painless method for increasing the skin permeation of many drugs, including ketamine. Transdermal delivery systems offer several advantages over inhalation and intravenous administration. PharmaTher‘s approach with ketamine consists of a 2-part system comprised of a drug-loaded reservoir placed on top of the hydrogel microneedle array. After administration into the skin (i.e. intradermal delivery), the microneedles become hydrated and swell, creating pores for the reservoir to release the drug content into the tissue over the treatment course. Upon removal, the needles are intact, yet rounded, and do not need to be disposed of as sharps. The drug enters the systemic circulation circumventing absorption and first-pass barriers typical for oral delivery. Studies have shown that systemic drug concentrations are reached minutes after administration and maintained over multiple days with transdermal delivery. This system addresses a major unmet need by offering greater ease of administration and including patients with pre-existing conditions that exempt them from oral or inhalation dosing. In addition, it avoids syringe needles, eliminating pain and patient visits to a clinician.

Potential of the Ketamine Microneedle Patch

The Company’s patented hydrogel-forming microneedle (“MN”) patch aims to deliver ketamine for intradermal administration to treat various mental health, neurological and pain disorders. The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.2 The MN patch is tailored for ketamine due to the required drug volume to maximize their therapeutic utility and increase potential market opportunities.

The ketamine MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office. The ketamine MN patch has the potential for enabling continuous delivery of ketamine (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours, which will improve efficacy and compliance for patients.1-2 Also, the ketamine MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

Sources:
1.Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.

2.     Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.

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First Patient Dosed in Second Phase 2 Add-on Ketamine Trial in Treatment-resistant Depression (TRD)

First Patient Dosed in Second Phase 2 Add-on Ketamine Trial in Treatment-resistant Depression (TRD)

Dosing has commenced in HMNC Brain Health and Develco Pharma’s Phase 2 oral prolonged-release Ketamine (KET01) Study

The trial will assess the efficacy, safety, and tolerability of add-on treatment with KET01 in 117 patients suffering from Treatment-Resistant Depression (TRD)

Munich, June 8, 2022 – HMNC Brain Health (“HMNC” or the “company”), together with Develco pharma, today announced the dosing of the first patient in their second Phase 2 trial with oral prolonged-release Ketamine (KET01) for Treatment-Resistant Depression.

HMNC is a global precision psychiatry biopharma company, pioneering the development of personalized therapies powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects has partnered with Develco pharma, a company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs, in this trial.

The trial will assess the efficacy, safety, and tolerability of add-on treatment with Ketamine hydrochloride prolonged-release tablets (KET01) in patients suffering from Treatment-Resistant depression (TRD). It will enroll 117 TRD patients at approximately 38 clinical sites. The study’s selection criteria for patients to be included was defined by non-response to a minimum of two standard antidepressants in their current major depressive episode. The trial is expected to confirm the results of the previous trial, with early-onset of efficacy, showing placebo-level dissociative side effects, and excellent tolerability, furthering the take-at-home potential of this novel treatment.

“Our first investigator-initiated Phase 2 Proof of concept trial, which we announced the preliminary results for at end of March, suggested a positive trend in efficacy for KET01, which appears to be a safe and well-tolerated antidepressant with substantially limited dissociative side effects,” said Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health.

The Ketabon program, which is a joint venture between HMNC Brain Health and Swiss-based Develco Pharma, funded the trial. Patients will be randomized into three treatment groups and will either receive a placebo, KET01 120 mg, or KET01 240 mg once daily (OD), in addition to their ongoing standard antidepressant treatment over a period of three weeks. The primary endpoint is the change on the established Montgomery–Åsberg Depression Rating Scale (MADRS) for depressive severity at day 21 compared to placebo.

HMNC Brain Health CEO Benedikt von Braunmühl added: “We are very pleased to have achieved this important milestone in the development of KET01 for Treatment-Resistant Depression. We believe KET01 has the potential to improve the lives of patients who are not responding to standard antidepressant therapies, and we are looking forward to further develop this potential medication with the insights generated from this trial”.

Topline data from the study is expected to be reported in the second quarter of 2023.

ABOUT HMNC BRAIN HEALTH

HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company, pioneering the development of personalized therapies, powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects. The company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The company has operations in both the US and Germany and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. HMNC Brain Health now enters the next stage of its development with a large-scale licensing and fundraising agenda.

ABOUT DEVELCO PHARMA

With headquarters in Pratteln/ Switzerland, Develco Pharma is a Swiss-German pharmaceutical company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs containing known active ingredients. Established in 2006, today the company has a workforce of 130 employees. In Germany, a state-of-the-art production facility for analgesics & other indications has been in operation in Schopfheim, in the Baden region, since 2016. Develco identifies and defines pharmaceutical products containing known active ingredients and develops generic, hybrid, value added and innovative formulations backed by clinical data for the delayed or modified release of active ingredients. On the strength of its experience and innovativeness, the company has emerged as an internationally recognized provider of pharmaceuticals for the treatment of several disease areas. The customer base of Develco Pharma includes global pharmaceuticals groups. The company has some 180 market approvals in all (products of different dosages) in Europe, the US, Middle- East, South Africa, Asia,andAustralia.

ABOUT THE KETABON PROGRAM

The Ketabon program, a joint venture between HMNC Brain Health and Develco Pharma in Switzerland, comprises an oral prolonged-release formulation of ketamine for TRD with minimal dissociative side effects. The pharmacokinetic profile of the prolonged-release formulation could significantly improve the risk profile and patient convenience, by minimizing dissociative side effects compared to the currently applied intravenous and intranasal ketamine therapies. TRD patients with insufficient response to standard antidepressants represent 30% of an overall estimated number of 320 million patients worldwide suffering from major depressive disorder. In this group, prolonged-release ketamine has shown high response rates. Clinical development of oral prolonged-release ketamine could also be potentially expanded into other indications, such as anxiety, aggression, PTSD, and panic disorder.

Media contacts

Alexander Schmidt (Europe)
+49 151 22 99 39 765
alexander.schmidt@gaulyadvisors.com

Anne Donohoe (U.S.)
+1 212-896-1265
hmnc@kcsa.com

Investor Contact (U.S.)

Sophia Bashford
+1 929 246 7307
sbashford@kcsa.com

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Braxia Scientific Presents Positive Preliminary Findings from Phase II Randomized, Multi-Dose Clinical Trial of Psilocybin-Assisted Therapy for Treatment Resistant Depression

Braxia Scientific Presents Positive Preliminary Findings from Phase II Randomized, Multi-Dose Clinical Trial of Psilocybin-Assisted Therapy for Treatment Resistant Depression

TORONTO, June 2, 2022 / Braxia Scientific Corp. (“Braxia Scientific”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 4960), a medical research company with clinics providing and advancing innovative ketamine and psilocybin treatments for depression and related mental health disorders, is pleased to announce positive preliminary results from the first Health Canada Approved, Phase II, randomized clinical trial to evaluate the feasibility, safety, tolerability, and efficacy of multi-dose psilocybin-assisted therapy for Treatment-Resistant-Depression. The preliminary results were presented at the “From Research to Reality Conference” in Toronto, May 27-28, 2022.

Positive Preliminary Results Highlights

Braxia Scientific’s ongoing multi-dose psilocybin trial effectively demonstrated the feasibility of Braxia’s proprietary psilocybin-assisted therapy protocol with high rates of recruitment and retention with adequate tolerability and safety.
Clinically meaningful improvements in depression severity observed (as measured by the MADRS1) with complete analysis of antidepressant efficacy and secondary outcomes pending. This trial will be completed by December 2022 at which point the full analysis will be completed and submitted for publication.
Preliminary results indicate strong feasibility with adequate recruitment including 159 individuals who were referred to the study.
Retention – 93% of participants retained to primary endpoint.
Safety – No serious adverse events and zero suicide attempts to date.
Tolerability – majority of adverse effects resolving within 24 hours of each dose and 87% of participants requesting to receive a second dose.
Feasibility of Braxia Institute psychedelic therapy training program demonstrated through recruiting, retaining, and training group of multi-disciplinary independently licensed therapists that continue to serve as therapists as part of Braxia’s psilocybin trial. Group of therapists consists of psychiatrists, primary care therapists, psychotherapists and spiritual care.
(1) Symptoms of depression were assessed using the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression.

“These results clearly show that we have the infrastructure, expertise and personnel to effectively and safely provide psilocybin-assisted therapy. Dr. Joshua Rosenblat, Chief Medical and Scientific Officer, Braxia Scientific, and Principal Investigator. “While these preliminary results are highly encouraging, they also provide us with additional guidance as we evaluate and optimize our clinical protocols in delivering innovative, psychedelic treatments to patients with treatment resistant depression. These results also reinforce the potential value of the clinical infrastructure we have established to target new innovative treatments.”

Dr. Roger McIntyre, President and CEO, Braxia Scientific, “In addition to our ongoing trial that enables us to provide access to this treatment today, we are excited by the prospect these results with psilocybin may offer patients with treatment resistant depression, an area in need of therapeutic innovation. In addition to guiding professionals internationally on the safe and effective implementation of ketamine, Braxia Scientific is also conducting highly rigorous clinical research with psilocybin, ketamine, and related agents with the aim to provide eligible persons with innovative treatments that work rapidly and are safe to administer.”

Accessing Psilocybin and Ketamine in Canada

Braxia Scientific is a leader in providing access to innovative rapid acting treatments such as ketamine and psilocybin for people living with treatment resistant depression. Braxia Scientific was the first to receive Health Canada approval for a multi-dose psilocybin-assisted therapy clinical trial in July 2021, and dosed its first participant in November 2021. This ongoing clinical trial provides Canadians with immediate access to psilocybin for treatment resistant depression.

Recently, Braxia Scientific also recently announced its among the first to receive approval for psilocybin-assisted therapy treatment approval in Ontario using Health Canada’s Special Access Program (SAP). The SAP was amended January 5th, 2022 to include access to psychedelic compounds on a case-by-case basis outside of clinical trials.

Canadians interested in applying to the SAP, to participate in clinical trials or to qualify for other treatments, such as IV and oral Ketamine for the treatment of depression, may contact the medical team at Braxia Health (the Canadian Rapid Treatment Centre of Excellence https://crtce.com).

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 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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COMPASS Pathways presents largest ever study of psilocybin therapy, at American Psychiatric Association annual meeting

COMPASS Pathways presents largest ever study of psilocybin therapy, at American Psychiatric Association annual meeting

Positive data from phase IIb study shows potential of COMP360 psilocybin therapy
in treatment-resistant depression

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today presented positive data from the largest randomised, controlled, double-blind study of psilocybin therapy ever completed, at the American Psychiatric Association annual meeting in New Orleans*. The study showed that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after three weeks (p<0.001), with a rapid and durable response for up to 12 weeks.

The randomised, controlled, double-blind phase IIb clinical trial was designed to understand the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg in patients with treatment-resistant depression (TRD). 233 patients with TRD received either 1mg, 10mg or 25mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists. Symptoms of depression were assessed using the Montgomery-Åsberg depression rating scale (MADRS)**, a widely used and accepted scale for assessing depression; the MADRS assessments were made by an independent, blinded rater.

Key results:

  • Depression symptoms: patients who received a 25mg dose of COMP360 psilocybin with psychological support experienced a highly statistically significant reduction in symptoms of depression after three weeks: the difference between 25mg group and 1mg group was -6.6 on the MADRS* depression scale at week 3, p<0.001.
  • Durability: double the number of patients who received 25mg had a sustained response at week 12, compared to those who received 1mg (20.3% of patients in the 25mg group vs 10.1% in the 1mg group).
  • Tolerability: COMP360 psilocybin was generally well-tolerated. On the day of COMP360 administration, headache, nausea, and dizziness were the only adverse events where a dose-related increase in incidence was evident and there were no clinically significant differences between dose group in vital signs or clinical laboratory tests observed during the study.
  • Adverse events: In this study suicidal ideation and intentional self-injury were seen in all treatment groups (as is regularly observed in a TRD population), and the majority occurred more than a week after the psilocybin session. There was no mean worsening of suicidal ideation scores in any treatment group. Suicidal behaviours were reported at least 1 month after COMP360 administration for 3 non-responders in the 25mg arm.

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 one of the biggest challenges we face in psychiatry, and chances of success decreases with each treatment that a patient tries. It’s rare to see such positive outcomes of clinical trials in this disease area, which is why these results are so significant. I hope this represents a major step in finding new options for people living with treatment-resistant depression.”

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said, “Our mission is all about developing mental health innovations through scientific evidence, which is why we’re so honoured to present the largest study of its kind at the APA. In this study, a significant number of patients experienced improvement in their symptoms of depression after just a single dose of 25mg psilocybin with psychological support, with effects lasting for up to three months of the study. We now need to continue our research to understand if this can be replicated in even larger trials.”

Hear Professor David Hellerstein talk about the study

-Ends-

*The safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression: Results from a phase IIb randomized controlled trial. Guy M. Goodwin, Susan C. Stansfield, David J. Hellerstein, Allan H. Young, Ekaterina Malievskaia. APA: Abstract Number: 5301 Session Title: Poster Session 6

**MADRS = Montgomery-Åsberg Depression Rating Scale; response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10; sustained response = patients meeting the MADRS response criteria from week 3 until week 12

About treatment-resistant depression (TRD)

More than 320 million people globally suffer with major depressive disorder (MDD)1, the leading cause of disability worldwide and one of the fastest growing mental health illnesses2. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with treatment-resistant depression (TRD)3. As many as 30% of these attempt suicide at least once during their lifetime4,5. 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 patients6. 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.

About the COMP360 psilocybin therapy phase IIb study

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.

The trial assessed 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 was 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. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is 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 business strategy and goals, including its ability to launch and commercialise products, COMPASS’s ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy. 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 10-K filed with the US Securities and Exchange Commission (SEC) on 24 February 2022 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: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

References:

[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 [Accessed 21 October 2021]
[2] 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]
[3] Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.
[4] 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
[5] 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
[6] 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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Beckley Psytech Announces Partnership With Empatica in Latest Step of Digital Strategy, Designed to Deliver Personalised Patient Care

Beckley Psytech Announces Partnership With Empatica in Latest Step of Digital Strategy, Designed to Deliver Personalised Patient Care

  • Partnership will capture behavioural and physiological signals and predictive biomarkers in Beckley Psytech’s upcoming Phase 2 clinical trials
  • New digital strategy aims to improve patient outcomes and safety by integrating advanced digital tools into the psychedelic treatment journey
EmbracePlus is a medical-grade wearable that enables the passive, remote monitoring of physiological and behavioural signals. Photo credit: Empatica

EmbracePlus is a medical-grade wearable that enables the passive, remote monitoring of physiological and behavioural signals. Photo credit: Empatica

May 19, 2022 02:00 AM Eastern Daylight Time

OXFORD, England–(BUSINESS WIRE)–Beckley Psytech Limited, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, and Empatica, Inc., a medical wearables and digital biomarker company offering continuous, passive, and unobtrusive monitoring for patients with neurological conditions, today announced that the companies have entered into a partnership to support the collection and analysis of behavioural and physiological data in Beckley Psytech’s future clinical trials.

This partnership will utilise Empatica’s medical-grade EmbracePlus wearable and software, to identify and measure passive behavioural and physiological signals in the upcoming Phase 2 studies evaluating the use of 5-MeO-DMT in combination with psychotherapy in the treatment of treatment resistant depression (TRD).

The strategic partnership with Empatica is the latest step in Beckley Psytech’s digital strategy to develop personalised treatment programmes for patients in need. The digital enhancement of the psychedelic treatment pathway aims to support patients before, during, and after treatment through the application of novel, predictive biomarkers which will potentially identify early signals of patient response and relapse.

Beckley Psytech aims to establish a complete, end-to-end personalised psychedelic treatment programme, combining advanced digital phenotyping capabilities, such as those developed by Empatica, with psychedelic-assisted psychotherapy. This will allow clinicians to provide patients with continuous access to personalised therapy support beyond their treatment, delivering potentially improved outcomes and safety for patients and healthcare systems.

Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “As we look to enhance the safety and effectiveness of our psychedelic treatments with patient-centric digital tools, this partnership with Empatica accelerates our strategy of creating an integrated treatment model to ensure patients are fully supported through the treatment journey. We are thrilled to be working with Empatica, a pioneering digital health company, through our upcoming clinical trials and look forward to further evolving our understanding of how digital tools can support and potentially improve outcomes for patients with neurological and psychiatric conditions.”

Matteo Lai, CEO of Empatica, commented: “We couldn’t be more excited to collaborate with Beckley Psytech on this important project, especially since over the past two years, we have witnessed how critical mental health and depression have become globally. The potential of psychedelic treatments in the field can help millions of patients, and Empatica is honored to contribute its technology in one of the world’s first trials with psychedelics and digital tools, to advance these novel therapies with targeted help and better engagement.”

About 5-MeO-DMT
5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychoactive compound which binds to a variety of receptors within the brain pertaining to serotonin. A psychedelic substance which occurs naturally in a number of plant species, as well as in the Sonoran Desert toad, studies have indicated that 5-MeO-DMT is associated with improvements in mood, anxiety, reduced stress, increased life satisfaction and mindfulness. 5-MeO-DMT has been reported to produce mystical experiences with comparative intensity as seen with high doses of psilocybin but has a significantly shorter duration of effect. Beckley Psytech is developing proprietary synthetic intranasal formulations of 5-MeO-DMT (BPL-002 and BPL-003) and plans to evaluate their potential therapeutic effects in patients suffering from Treatment Resistant Depression, as well as other Mood and Use Disorders indications.

Beckley Psytech – www.beckleypsytech.com
Beckley Psytech is a clinical stage privately held company dedicated to helping patients suffering from neurological and psychiatric disorders by developing a broad pipeline of psychedelic compounds in rare and more common diseases. Our vision is for clinically validated psychedelic medicines to be integrated into modern medical practice in order to help patients with high unmet medical need around the world suffering with treatment resistant depression, and other profoundly debilitating neurological conditions. Beckley Psytech was founded in 2019 leveraging some of the expertise developed over more than 20 years by the Beckley Foundation, an independent non-profit and world leader in psychedelic medicine research, and is based out of Oxford, United Kingdom.

Empatica – www.empatica.com
Empatica Inc is a pioneer in continuous, unobtrusive, and remote health monitoring driven by AI. Empatica’s platform combines accurate digital biomarkers, software and wearables to monitor multiple conditions. Empatica’s products are used by thousands of institutional partners for research purposes, in trials and studies examining Stress, Sleep, Epilepsy, Migraine, Depression, Addiction, and other conditions.

Contacts

Beckley Psytech
Cosmo Feilding Mellen
Chief Executive Officer
info@beckleypsytech.com

Communications
FTI Consulting
Ben Atwell / Mike Trace
+44 (0)20 3727 1000
beckleypsytech@fticonsulting.com

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
+41 76 735 01 31
gvanrenterghem@lifesciadvisors.com

Empatica
Marianna Xenophontos
Director of Marketing
mx@empatica.com

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Legal psilocybin therapy comes to Quebec

Numinus Wellness Receives Health Canada Special Access Program Applicant Approval to Provide Psychedelic-assisted Therapy Treatment

After several unsuccessful depression treatments, a patient in Quebec will finally get to try psilocybin therapy through the Special Access Program (SAP), marking the first legal psilocybin treatment in the province.

Numinus Wellness (NUMI) received Health Canada approval to administer the treatment at its Montreal clinic. It will be the company’s first treatment outside of a clinical trial setting.

Hopefully we’ll start seeing more wins like this thanks to TheraPsil, a non-profit that launched an initiative to make it easier for patients to access psilocybin through the SAP. 

The initiative, called Project Solace, will secure a safe supply of psilocybin from HAVN Life (HAVN) and other licensed dealers and collect data on treatment outcomes to support policy change. 

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Zylorion Receives Approval for Phase II Clinical Study for its Proprietary Almond Therapy™

Zylorion Receives Approval for Phase II Clinical Study for its Proprietary Almond Therapy™

First of its kind study to investigate the effects of Almond Therapy in TRD patients receiving intranasal esketamine.

CALGARY, AB, May 10, 2022 /CNW/ –  PsiloTec Health Solutions Inc., operating as Zylorion Health, (“Zylorion” or the “Company”), a mental health care and psychedelic therapy focused innovator, is pleased to announce it has received approval from the Health Research Ethics Board of Alberta (the “HREBA”) to conduct a phase II clinical study for patients suffering from treatment-resistant depression (“TRD”).

Approximately 320 million people globally suffer from major depressive disorder (“MDD”). Of this population, roughly one-third do not respond to conventional antidepressants, a condition known as treatment-resistant depression.   

The first of its kind, single-blind, randomized, controlled, phase II clinical study will look at clinical outcomes of 102 patients suffering from TRD. The study participants will be observed in two groups. The first group will undergo treatment receiving standard and approved intranasal esketamine (“Spravato”). The second group will undergo treatment receiving both Spravato and Zylorion’s proprietary multi modal therapy, Almond Therapy.      

The primary outcome of the clinical study will be to determine if augmentation with Almond Therapy leads to better patient outcomes, as assessed using the Montgomery-Asberg Depression Rating Scale (“MADRS”), a standardized interview measure for depression.

“This marks a very important milestone for Zylorion and for Almond Therapy. While new psychedelic compounds bring hope for the roughly one billion people around the world suffering from mental illness, we strongly believe that these powerful compounds should be administered in combination with appropriate therapy, for both the safety of the patient and to achieve the best clinical and sustainable outcomes,” commented Dr. Peter Silverstone, Chief Executive Officer. “We are committed to taking an evidence-based approach to achieving our goal of improved patient outcomes, and this clinical trial is a pivotal step to demonstrating the incremental efficacy of Almond Therapy.” 

The clinical study is expected to begin in Q2 2022 and is anticipated to finish recruitment in the next 12 to 18 months. The study will adhere to International Conference on Harmonization (“ICH”) guidelines for Good Clinical Practice (“GCP”), as well as local regulatory requirements. About Almond Therapy™

Almond Therapy is a proprietary intensive multi modal therapy program that is specifically designed to be delivered in combination with psychedelic drug treatment. Almond Therapy takes a blended approach to therapy delivery and utilizes elements of multiple evidence-based programs. About Zylorion

Zylorion is a biopharmaceutical company engaged in the development and delivery of integrated mental health therapies to address psychological and neurological mental health conditions. Zylorion is focused on the research, development and commercialization of psychedelic-based compounds, coupled with novel therapeutic treatment programs targeting a continuum of mental health conditions, such as MDD (major depressive disorder), TRD (treatment resistant depression), PTSD (post-traumatic stress disorder), general depression, anxiety disorders, and a number of addictive tendencies. Zylorion aims to leverage leading technologies to support the scalability and accessibility of its integrated therapy programs in its mission to enable those experiencing mental health challenges to thrive.Cautionary Note Regarding Forward-Looking Statements

This news release contains statements that constitute forward-looking information (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information.

SOURCE Zylorion

For further information: Investor Relations: InvestorRelations@zylorion.com;General Enquiries & Media Relations: Info@zylorion.com, www.zylorion.com

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COMPASS announces new psilocybin therapy findings

COMP360 psilocybin therapy shows potential in exploratory open-label studies for anorexia nervosa and severe treatment-resistant depression

New studies suggest that COMPASS Pathways’ proprietary psilocybin has promise in treating some of the most challenging mental health conditions: severe treatment-resistant depression and anorexia nervosa.

After a single dose of psilocybin, 58.3% of patients with severe treatment-resistant depression (meaning they’d tried 5+ antidepressant treatments without success) had a reduction in depression scores for 12 weeks.

One quarter of patients no longer qualified for a depression diagnosis.

In the anorexia study, 30% of patients had significant reductions in symptoms at the 1-month follow up, increasing to 40% at the 3-month follow up.

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Biomind begins DMT trial

Biomind Labs Doses First Subject in Phase I/IIa Clinical Trial of Its DMT-Based Inhaled Formulation BMND01 for Treatment-Resistant Depression

Biomind Labs (BMND) dosed the first subject in a Phase I trial /IIa clinical trial on DMT for treatment-resistant depression.

Over the next 4 months, 30 healthy patients who have never done psychedelics will receive 2 doses of inhalable DMT. Researchers will assess the safety of the drug, as well as behavioral and brain effects before continuing with Phase II.

Can you imagine trying DMT as your first psychedelic?

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Beckley Psytech Announces Dosing of First Healthy Volunteers in Phase 1 Clinical Trial Assessing Safety and Pharmacokinetics of Second Innovative Formulation of 5-MeO-DMT

Beckley Psytech Announces Dosing of First Healthy Volunteers in Phase 1 Clinical Trial Assessing Safety and Pharmacokinetics of Second Innovative Formulation of 5-MeO-DMT

  • Study represents continued efforts to further understand the clinical and pharmacological potential of 5-MeO-DMT
  • BPL-003 is Beckley Psytech’s innovative dry powder intranasal formulation of 5-MeO-DMT using FDA approved intranasal delivery devices
  • Data from Phase 1 will be used to select lead compound for upcoming Phase 2 in treatment resistant depression (TRD)

April 05, 2022 02:00 AM Eastern Daylight Time

OXFORD, England–(BUSINESS WIRE)–Beckley Psytech, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, announced that the first healthy volunteers have been dosed in a Phase 1 clinical trial exploring the safety and pharmacokinetics of BPL-003, Beckley Psytech’s second innovative formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT).

“We are committed to exploring the full therapeutic potential of psychedelic medicines. By looking to tailor the potential therapeutic effects of these compounds through dose and delivery mechanisms, such as FDA approved devices, we aim to optimise treatment outcomes and reduce the burden on the patient, healthcare systems and society.”Tweet this

The Phase 1 study is designed as a double-blind, randomised, single ascending dose study to evaluate the safety and pharmacokinetics of BPL-003 in psychedelic-naïve healthy subjects. The study will recruit up to 36 participants (dependent on response) in 6 cohorts of 6 healthy volunteers on increasing doses.

A separate Phase 1 study is ongoing, evaluating the safety and pharmacokinetics of BPL-002, a liquid intranasal formulation of 5-MeO-DMT.

While both BPL-002 and BPL-003 are formulations of 5-MeO-DMT, BPL-003 is a benzoate formulation of 5-MeO-DMT and is administered as a dry powder intranasal spray. This dry powder formulation may provide potential benefits in tolerability and absorption characteristics, and could potentially change the manner in which patients experience the treatment. Both BPL-002 and BPL-003 use FDA approved intranasal delivery devices.

The data from both Phase 1 studies will then be analysed to determine which formulation will be used in the upcoming Phase 2 studies, aimed at evaluating the use of 5-MeO-DMT in combination with assisted psychotherapy in the treatment of treatment resistant depression (TRD) and other indications.

Dr Frank Wiegand, CMO of Beckley Psytech, said: “At Beckley Psytech patients are at the centre of everything we do. Therefore we are thrilled with the initiation of this second Phase 1 study which is investigating our innovative dry powder formulation for its potential to optimise the delivery of 5-MeO-DMT, through improved tolerability and adsorption characteristics. The results from this study will allow us to determine the optimal formulation for our upcoming proof of concept and Phase 2 studies in TRD and the other indications we will be exploring.”

Cosmo Feilding Mellen, CEO of Beckley Psytech, added: “We are committed to exploring the full therapeutic potential of psychedelic medicines. By looking to tailor the potential therapeutic effects of these compounds through dose and delivery mechanisms, such as FDA approved devices, we aim to optimise treatment outcomes and reduce the burden on the patient, healthcare systems and society.”

Phase 1 study overview

The Phase 1 study is a double-blind, randomised, single ascending dose trial, with psychedelic-naïve healthy volunteers. The study will enrol up to 36 volunteers to evaluate the safety and pharmacokinetic characteristics of a dry powder intranasal spray of 5-MeO-DMT. The trial will also look to characterise the psychedelic experience of the subjects, with several scales and micro-phenomenology interviews carried out by a specialist to fully understand the experience of each individual.

Beckley Psytech – www.beckleypsytech.com

Beckley Psytech is a clinical stage privately held company dedicated to helping patients suffering from neurological and psychiatric disorders by developing a broad pipeline of psychedelic compounds in rare and more common diseases. Our vision is for clinically validated psychedelic medicines to be integrated into modern medical practice in order to help patients with high unmet medical need around the world suffering with treatment resistant depression, and other profoundly debilitating neurological conditions. Beckley Psytech was founded in 2019 leveraging some of the expertise developed over more than 20 years by the Beckley Foundation, an independent non-profit and world leader in psychedelic medicine research, and is based out of Oxford, United Kingdom.

Contacts

Beckley Psytech
Cosmo Feilding Mellen
Chief Executive Officer
info@beckleypsytech.com

Communications
FTI Consulting
Ben Atwell / Mike Trace
+44 (0)20 3727 1000
beckleypsytech@fticonsulting.com

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
+41 76 735 01 31
gvanrenterghem@lifesciadvisors.com