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US military to study psychedelic therapy?

GOP Congressman’s Amendment Would Direct Military To Study Psilocybin And MDMA Benefits For Service Members

Last week, an amendment calling for the Department of Defense (DOD) to study medical cannabis for military service members was approved by a House Committee.

Now, Rep. Matt Gaetz (R-FL) is pushing for the amendment to be expanded to include psilocybin and MDMA. If approved the DOD would be required to study the therapeutic potential of the drugs as alternatives to opioids prescribed for chronic pain.

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MDMA-Assisted Group Therapy for PTSD Among Veterans Study Will Proceed Following Successful Safety Negotiations

MDMA-Assisted Group Therapy for PTSD Among Veterans Study Will Proceed Following Successful Safety Negotiations

  • The FDA lifted the clinical hold from a MAPS-sponsored Phase 2 study of MDMA-assisted group therapy for the treatment of posttraumatic stress disorder among veterans at the VA Portland Health Care System
  • This essential proof-of-principle study tests safety and logistics of group therapy, the first step in fully investigating the treatment for efficacy and broader patient access
  • The data-driven negotiation strategy included substudies of participants’ no-overnight stay conducted in the first Phase 3 trial of MDMA-assisted therapy for PTSD

After months of negotiations with the U.S. Food and Drug Administration (FDA), the Multidisciplinary Association for Psychedelic Studies (MAPS) has been permitted to initiate the MAPS-sponsored Phase 2 Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder (PTSD) in Veterans (MPG1). Despite its status as the world’s leading research center for PTSD, few Veterans Affairs (VA) facilities have hosted clinical trials of MDMA-assisted therapies for PTSD. 

Though the study was approved by the VA Portland Health Care System Institutional Review Board months earlier, the FDA placed a partial clinical hold due to a theoretical safety concern surrounding a perceived need for overnight stays at the trial location, a requirement that was not part of the proposed study protocol. In response to the clinical hold, MAPS submitted safety data from a Phase 3 sub-study; the FDA agreed to lift the clinical hold on June 15, 2022.

In the early Phase 2 studies, we included overnight stays as an opportunity for the participants to rest and integrate what unfolded during their MDMA-assisted therapy session. Though we had no data to suggest there was a concern about safety overnight, these stays became required from the FDA perspective. In the Phase 3 program, we’re collecting safety data from participants with and without overnight stays to gather evidence to whether overnight stays are necessary. From the data we have so far, that doesn’t seem to be the case. We are pleased that the safety data in the Phase 3 substudy without overnight stays could support the FDA in making the data driven decision to permit no overnight stays in this important group study research.

Allison Coker, Ph.D., Associate Director of Regulatory Affairs, MAPS PBC

The study is conducted by MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS, led by Chris Stauffer, M.D., and hosted within the VA Portland Health Care System. Eighteen Veterans in three cohorts of six will undergo the first of two MDMA-assisted therapy sessions individually and the second treatment session in their group cohort, along with individual and group preparation and integration sessions. If MAPS’ appeal was not granted, each cohort of six Veterans would have been obligated to stay overnight in the VA hospital after their MDMA-assisted therapy sessions. 

There is so much yet to explore regarding the relational potential of MDMA-assisted therapy, and research on group therapy combined with MDMA sessions is a logical next step. What drives this work for me are the unique therapeutic properties of group cohesion that I’ve witnessed in my previous group therapy trials with oxytocin and psilocybin. If the FDA finds MDMA-assisted therapy to be safe and effective, the benefit of the group model for scalability and access could be an added bonus. My team and I are grateful that the FDA is permitting our innovative MDMA-assisted group therapy protocol, including sending Veterans home after MDMA sessions with a pre-screened and informed support person, to proceed.

Chris Stauffer, M.D., Principal Investigator for MPG1

The first Phase 3 trial of MDMA-assisted therapy for PTSD achieved encouraging results among participants with severe, chronic PTSD: two months after the final experimental session, 88% of participants experienced a ≥10 point reduction in PTSD symptoms and 67% no longer met the criteria for a diagnosis of PTSD. MDMA may be an effective catalyst for other therapy modalities commonly used in the treatment of PTSD. MAPS PBC is collaborating with experts in these modalities, trained through the MDMA Therapy Training Program, to explore the potential of other treatments through proof-of-principle studies such as MPG1. Group therapy, which can be a highly effective treatment for people with common experiences, may also be highly effective at reducing costs for patients. If this trial indicates the treatment may be safe and effective, further research of group therapy will be pursued as one element of MAPS’ comprehensive patient access and health equity programs.   

NOTE
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA or other regulatory authorities, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future regulatory approval or availability of MDMA-assisted therapy.

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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 MAPS was founded, philanthropic donors and grantors have given more than $130 million for psychedelic and marijuana research and education. MAPS has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.

ABOUT MAPS PUBLIC BENEFIT CORPORATION
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, commercialization, and patient access 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. MAPS PBC is the parent company of MAPS EU, formed to organize and administer clinical trials of investigational MDMA-assisted therapy for PTSD in the United Kingdom and European Union.

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Optimi Health Initiates Agreement With Sabi Mind for Therapeutic Supplies of Psilocybin, MDMA

Optimi Health Initiates Agreement With Sabi Mind for Therapeutic Supplies of Psilocybin, MDMA

JUNE 28, 2022 CORPORATE NEWS

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a homegrown, Canadian company producing natural, scalable, and accessible psychedelic and functional mushrooms, as well as synthetic formulations for transformational human experiences, is pleased to announce that it has entered into a supply agreement with SABI Mind, a Calgary-based clinic group providing psychedelic-assisted therapies.

The Company has signed an agreement which will provide SABI Mind’s trained clinical staff with supplies of GMP psilocybin and 3,4-Methylenedioxymethamphetamine (“MDMA”), pending the anticipated approval of its previously announced licensing amendment, for use by practitioners in psychedelic-assisted therapeutic protocols with approved patients via Health Canada’s Special Access Program, clinical trials, and academic studies.

“This agreement is an important step forward for both parties,” said Optimi Health CEO Bill Ciprick. “SABI Mind’s initiation of this agreement demonstrates a commitment to safe supply for the development and implementation of therapeutic modalities using psilocybin and MDMA.”

Clinical distribution is a major milestone in the growth of Canada’s psychedelics sector from the standpoints both of business operations, and as a medical option for those in need.

“There’s growing evidence that MDMA and psilocybin assisted therapies can help treat PTSD, depression and other chronic mental health conditions,” said Philippe Lucas PhD, SABI Mind President. “We’re very pleased to be working with Optimi to ensure a safe, consistent supply of psilocybin and MDMA to SABI patients qualifying under Health Canada’s Special Access Program.”

“As we continue to establish the logistical channels of our new industry, Optimi is extremely gratified to receive requests such as this,” added Ciprick. “The knowledge that the substances we produce, natural or synthetic, will be used by patients in a safe environment to further psychedelic science is a vindication of the principles on which this company was established.”

Optimi Health recently requested an amendment to its Controlled Substance Dealer’s Licence from Health Canada which would enable it to utilize its state-of-the-art analytical laboratory for the production of synthetic MDMA, among other substances.

SABI Mind currently operates a best-in-class clinic in the Sunalta area of Calgary, with expansions planned into Edmonton, Alberta and Victoria, British Columbia.

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other synthetic psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

About SABI Mind

Located in Calgary, SABI Mind supports the careful and necessary mending of mental health and chronic pain through psychedelic-assisted therapies. Founded by a group of Calgary-based entrepreneurs brought face-to-face with the challenges of those suffering from mental health conditions, SABI Mind empowers those discouraged by the conventional medical methods with a patient-centered treatment model supported by experienced psychiatrists, anesthesiologists, therapists, client experience specialists, and other clinic staff specially trained in ketamine-assisted psychotherapy and other psychedelic therapies.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations
Michael Kydd
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: https://optimihealth.ca

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.

Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

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PharmAla Biotech Registers Trademark for MDMA

PharmAla Biotech Registers Trademark for MDMA

The Company’s clinical-grade GMP MDMA product is now known as “Laneo”

VANCOUVER, June 24, 2022 (Canada Newswire) – PharmAla Biotech (CSE:MDMA) has registered a trademark for its clinical-grade MDMA product, which shall be marketed as Laneo MDMA. PharmAla is currently the only publicly-traded company to have developed a full manufacturing value chain for MDMA.

“While MDMA is a generic drug, there’s a huge difference between illicit drug manufacture and our clinical-grade product. Only one is appropriate for use in scientific research: Laneo MDMA,“ said Nick Kadysh, CEO of PharmAla Biotech. “With this trademark registration, PharmAla continues to establish itself as the leader in MDMA manufacture, research, and development.”

A number of customers have already made deposits for Laneo MDMA, and the company anticipates initial product deliveries to be made in Fall of 2022. Laneo MDMA is initially available to customers in both a 40mg formulated clinical trial capsule and as pure Active Pharmaceutical Ingredient (API) which can be compounded by a qualified pharmacist. In the future, a range of drug product formulations can be developed.

“We’re speaking to customers every day who are excited to initiate clinical trials with MDMA – but they are unable to do so because up until now, they didn’t have access to clinical trial supply of drug product,” said David Purcell, Director of Sales at PharmAla Biotech. “PharmAla Biotech’s Laneo MDMA is the answer.”

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

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MAPS under fire for alleged investigator misconduct

MDMA trials under review in Canada over alleged abuse of study participants

Health Canada is reviewing all previously approved MDMA trial applications after a former trial participant came forward with sexual assault allegations.

Footage from MAPS’ PTSD trial in 2015 shows patient Meaghan Buisson being physically restrained and spooned by two therapists (one of them unlicensed) during an MDMA therapy session.

The session was recorded to ensure that therapists were following treatment protocols, but the footage wasn’t actually reviewed for 6 years. MAPS is finally looking into recordings from all past patients.

“I just want people to realize, this is not against MDMA. This is not against psychedelics,” Meaghan ensures.

“I’m just saying that if this drug is going to be legalized and medicalized in this way, then there is a certain degree of safety and fiduciary responsibility and credibility that goes into being part of the medical system — and especially with vulnerable subjects.”

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Optimi Health Requests Approval to Manufacture MDMA, Other Synthetic Psychedelics

Optimi Health Requests Approval to Manufacture MDMA, Other Synthetic Psychedelics

Company to maximize world-class EU-GMP operations, potentially opening future revenue-generating opportunities

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi”) or the (“Company”), a homegrown, Canadian company producing natural, scalable, and accessible mushroom formulations for transformational human experiences, has submitted a request with Health Canada for an amendment to its Controlled Substances Dealer’s Licence.

The amendment would enable the Company to synthesize, process and distribute pharmaceutical grade 3,4-Methylenedioxymethamphetamine (“MDMA”), among other substances, at its Princeton, British Columbia facility.

With the Company’s main capital expenditure now completed, it will move to expand its offering to encompass a wide variety of synthetic psychedelics through its market-leading EU-GMP cultivation and analytical laboratory. The move aligns with Optimi’s planned year of commercialization, allowing the Company to maximize revenue-generating opportunities through standardized psychedelic drug testing, R&D, and product development through approved clinical trials and exemption-based applications.

Ongoing large-scale studies, including Phase III clinical trials investigating MDMA conducted by the Multidisciplinary Association for Psychedelic Studies (“MAPS”), along with more recent decriminalization initiatives announced in the Province of British Columbia, have generated significant unmet demand for these substances for research purposes.

Optimi Health Chief Science Officer Justin Kirkland stated that, “Since our inception, Optimi has received a steadily increasing volume of inquiries related to the production of synthetic psychedelics from stakeholders within the sector, made all the more timely by recent developments. Our analytical laboratories were purpose-built to enable us to act as an EU-GMP compliant drug manufacturer for these interests, without in any way detracting from our primary goal of cultivating natural psilocybin.”

Mr. Kirkland elevates Optimi as an industry leader utilizing his drug manufacturing expertise shown in his USPTO awarded Bromo-LSD manufacturing patent sold in 2020 for C$10M and GMP regulatory knowledge from his role as CEO at FDA registered Fristoe Pharmaceuticals.

Optimi CEO, Bill Ciprick, says the Company’s EU-GMP operational footprint and throughput capacity is unmatched in North America and would likely take new entrants into the space years and millions of dollars to meet Optimi’s scale and clinical efficiency.

“We have a strong idea of our position in the market and how the amendment fits with our strategic priorities,” said Ciprick. “We are filing this amendment following conversations with researchers and drug developers which have led to a high volume of requests for GMP-compliant synthetic psychedelics. The positive reports from trauma sufferers, including veterans groups, for whom substances such as MDMA might make a difference, mean that safe, scalable supply is going to be more crucial than ever to the success of psychedelic medicine.”

“As we continue with our planned year of commercialization, Optimi views the capacity to produce and distribute these substances as integral to our overall positioning and revenue generation within the sector’s supply chain,” Ciprick concluded.

The Company’s amendment application to Health Canada also includes:

N,N-Dimethyltryptamine (“DMT”);
3,4,5-trimethoxyphenethylamine (“Mescaline”);
2-(2-chlorophenyl)-2- (methylamino)cyclohexanone (“Ketamine”);
Lysergic Acid Diethylamide (“LSD”);
1-(1-phenylcyclohexyl)piperidine (“Phencyclidine”);
4-Hydroxybutanoic Acid (“GHB”);
4,9–dihydro–7–methoxy–1–methyl–3H–pyrido(3,4–b)indole (“Harmaline”);
4,9–dihydro–1–methyl–3H–pyrido(3,4–b)indol–7–ol (“Harmalol”);
Salvia Divinorum, Salvinorin A; and,
4-Bromo-2,5-Dimethoxybenzeneethanamine (“2C-B”).

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: https://optimihealth.ca

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.

Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

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How to Change Your Mind comes to Netflix!

How to Change Your Mind | Official Trailer | Netflix

The most famous book on psychedelics becoming a Netflix series this July 12th.

If you haven’t read Michael Pollan’s best-selling book How to Change Your Mind, you’re missing out. The book provides one of the most comprehensive summaries on the history and future of psychedelic research, covering so many fascinating details that we could never fit in this 5-minute newsletter.

Now, the book is being transformed into a 4 part docu-series on the healing potential of LSD, psilocybin, MDMA, and mescaline. The 

The psychedelics sector gained a ton of traction after the documentary Fantastic Fungi was released — we can only imagine the positive impact this series will have!

Watch the official trailer

Buy the book

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Emyria expands MDMA analogue program with the University of Western Australia

Emyria expands MDMA analogue program with the University of Western Australia

We are thrilled to announce an extension of our existing partnership with the The University of Western Australia to develop an exclusive MDMA-analogue library.

The library, initiated by the highly-regarded research group led by Dr Matthew Piggott, is aimed at identifying MDMA-like compounds that could become treatments for neurological disorders as well as next-generation medicines used in psychotherapy.

“Emyria’s clinical development expertise, funding and international networks have taken our MDMA analogue research to the next level,” said Professor Piggott.

The field of medicinal psychedelic research is gathering steam, with the CSIRO also recently announcing a move into developing new treatments and improving existing ones.

Read more about the UWA agreement here

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A therapist’s experience with MDMA

I’m a Therapist Who Tried MDMA—Here’s How the Experience Shaped My Perspective on Psychedelic Therapy

Sara Reed, licensed marriage and family therapist, tried MDMA therapy as part of MAPS’ training program. Her experience deepened her understanding of herself and helped her process the loss of her grandmother. 

“As the medicine and the music carried me away, my grandmother appeared. Tears flowed down my face and joy filled my heart. It had been years since I had felt her presence like this. Seeing her in this bright, liberating light was an important part of my grieving process.

She took me to a place I knew existed but had never seen. I traveled to what felt like the essence of the universe, a space of Divinity, a place where I belonged. The vision revealed my presence within this enormous Whole—a place that had no beginning or end, where there is no distinction or separation from love. I call that place home. And for the first time in my adult life, I felt freedom. Me, a young Black woman. Free. Human.”

The experience also made Sara realize that the psychedelics industry needs to prioritize culturally sensitive care to make treatments safer and more accessible for BIPOC communities.

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PharmAla Biotech & SABI Mind Announce MDMA Supply Agreement

PharmAla Biotech & SABI Mind Announce MDMA Supply Agreement

PharmAla to supply SABI Mind’s Healing Centres, subject to Health Canada approval

VANCOUVER, May 19, 2022 (Canada Newswire) – PharmAla Biotech (CSE:MDMA) is pleased to announce that it has signed an agreement with SABI Mind Inc. which will allow for its GMP MDMA to be administered to patients at SABI Mind’s Healing Centres. SABI Mind is a leading and rapidly growing psychedelic clinic and research organization that provides psychedelic-assisted therapies in Calgary and at upcoming locations in Edmonton and Victoria.

“We’re very pleased to announce this supply agreement with PharmAla to increase access to psychedelic-assisted therapies for patients in need”, says Philippe Lucas PhD, President at SABI Mind. “Research has shown MDMA to be a safe and effective treatment for PTSD, end of life anxiety, and other treatment-resistant mental health issues, and our clinical team is looking forward to working with patients, Health Canada and the highly qualified team at PharmAla to provide MDMA-based treatments to authorized patients.”

Through this agreement, PharmAla will provide GMP, clinical-grade MDMA to SABI Mind, subject to regulatory approval. The MDMA will come from PharmAla’s GMP MDMA value chain, the first to be established in North America. As part of the agreement, PharmAla will have a right to access anonymized patient data collected during treatment by SABI Mind.

“I have long respected SABI and their principals for operating at high ethical and regulatory standards. Their work on developing the Canadian Psychedelic Survey prove that they are true academic leaders in the psychedelics industry,” said Nick Kadysh, PharmAla’s CEO. “As such, I think this is a natural partnership for both of our companies, and should allow for SABI Mind to expand their current offerings of psychedelic-assisted therapies.”

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.