Diamond Therapeutics Supports Health Canada’s Decision To Make Psilocybin Available Through Special Access Program

The announcement was made today by Health Canada in the Canada Gazette

TORONTO, January 5, 2022 / PRNewswire / – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic therapies for the treatment of mental health, Welcomes Health Canada’s Decision to Reverse Regulatory Changes made to the Special Access Program (PAS) in 2013 which prohibited access to restricted drugs, including psilocybin.

The goal of SSP is to provide Canadians with serious or life-threatening illnesses with access to emerging, life-saving drugs before they are officially approved. This change will allow physicians to request access to restricted medications on a case-by-case basis when other therapies have failed and when there is sufficient evidence of safety and efficacy for the treatment of the patient’s condition. Health from Canada This decision may offer patients who have not responded to existing therapies new avenues for care.

“Together with our partner Dalton Pharma Services, we are carefully evaluating how the recent change to the Special Access Program can enable us to help those in need,” said the CEO of Diamond. Judy Blumstock.

Diamond echoes Health Canada’s current position that clinical trials remain the best mechanism for expanding treatment options by generating scientific evidence that can lead to the approval of effective new drugs.

“At Diamond, we believe in the need to expand access to psilocybin in a safe and responsible manner through a rigorous clinical trial process,” said Blumstock.

In November 2021, Diamond began a Health Canada approved clinical trial to assess the pharmacokinetics and pharmacodynamics of low doses of psilocybin in healthy volunteers. The study is in progress.

The active pharmaceutical ingredient psilocybin used in this trial was manufactured by Dalton Pharma Services, which has an exclusive global partnership with Diamond to supply psilocybin to support clinical trials, research and future business opportunities.

Dalton is one of the few Canadian companies to have successfully manufactured psilocybin cGMP for use in an approved clinical trial. Dalton has already produced cGMP psilocybin in sufficient quantities for the planned Phase 2 clinical trials and Diamond’s research needs.

About Dalton Pharma Services
Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development and manufacturing services. We are FDA registered and Health Canada approved and bring over 30 years of experience to every project. We offer fully integrated solutions with a focus on speed, flexibility and quality. Our integrated services (drug discovery, formulation and process development, custom synthesis, cGMP sterile filling / finishing of liquids and powders, cGMP API manufacturing and / or dosage form manufacturing, and accelerated stability testing) into one location help us to be adaptable, flexible and profitable.

To learn more about Dalton’s history and abilities, please visit http://www.dalton.com

About Diamond Therapeutics
Diamond Therapeutics is a drug development company based in Toronto, Ontario. Our mission is to develop new and better therapies for mental health issues unleashing the promise of psychedelic compounds. Diamond is focused on sub-perceptual and non-hallucinogenic therapies that have potential for use on a large cohort of patients, thereby maximizing the positive impact that better drugs can have on global mental health.

To learn more about Diamond, visit www.diamondthera.com.

Cautions Regarding Forward-Looking Information
This press release includes certain “forward-looking information” under applicable Canadian securities laws. Forward-looking information includes statements other than statements of historical fact which may be identified by phrases such as “expects”, “anticipates”, “intends”, “objectives”, “plans” and “believes”. And are based on expectations, estimates and projections as of the date of this press release. Forward-looking statements contained in this press release include, without limitation, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in the treatment of mental health problems, and the timing and l completion of Diamond’s clinical trials and programs. Forward-looking information is necessarily based on a number of estimates and assumptions which, although considered reasonable, are subject to known and unknown risks, uncertainties and other factors that may cause actual results and future events differ materially from those expressed or implied. by such forward-looking statements. These factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; whereas factors may arise that may hamper Diamond’s future business plans; results of continuous development, marketing and sales; and other factors beyond Diamond’s control. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Therefore, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information contained in this press release, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Diamond Therapeutics Inc.

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