EXCLUSIVE: Canada Takes Center Stage With Large Scale Psilocybin Macrodose Trial

The Canadian biopharma company advancing at-home psilocybin microdose studies and supporting Veteran patients, Apex Labs Ltd., has received Health Canada’s approval for a comprehensive, “statistically powered” macro-and-multi dose advanced psilocybin trial on 160 patients. 

SUMMIT-90 is the company’s double-blind, placebo-controlled, multi-site and in-clinic Phase 2b study assessing repeated macrodoses of its synthetic psilocybin APEX-90 paired with proprietary psychotherapy on participants, all of whom suffer from severe depression with diagnosed PTSD.

The exact dose was selected to fill gaps in current macrodoses under study. Multiple doses will be provided over a period of three months, while the study is expected to last one year including screening, recruiting, treatment and post-treatment effects measurement.

With patient recruitment beginning sometime this quarter, the trial’s primary indication (severe depression within PTSD) is accompanied by secondary indications including standalone PTSD symptoms, chronic pain and anxiety that will be measured through scales assessing change from baseline in severity of symptoms.

Apex co-founder and CEO, Tyler Powell, says the federal agency’s approval “validates the urgent need for expanded healthcare options.” 

CMO Dr. Peter Tomlinson added that the dosing schedule was optimized in this trial toward “sustained efficacy” focusing on patients with the highest disease severity.

Apex’s ongoing take-home microdose psilocybin Phase 2b trial, PATHFINDER-52, had the proprietary psychedelic compound optimized to treat mild-to-moderate depression following a successful proof-of-concept clinical study and is set to begin dosing by mid-2023.

Both SUMMIT-90 and PATHFINDER-52 will be conducted through Centricity Research across five sites in Canada.

Apex CCC Greg Rutherford disclosed the company’s commercial path forward to Benzinga, which includes:

• Demonstrating measurable improved clinical and patient outcomes data vs. current standards of care in both standalone depression and anxiety and depression and anxiety with diagnosed PTSD, to ultimately facilitate an optimal and broad approved treatment label;

• Optimizing access to treatment assets by ensuring regulatory approval in Canada, U.S., EU and Australia, while also ensuring drug reimbursement and commercial listings; 

• Generating awareness of drug assets and ensuring the right patient targets secure access to treatment by partnering with key treatment stakeholders and developing additional tools and programs.

Rutherford, who has extensive experience in big pharma, believes stakeholders in the health space will “take notice” of the company once enrollment for both clinical trials begins, will then “digest” the studies’ results and, if endpoints are met and outcome data is strong, “they will begin pursuit.”

“The Pharma industry ideally looks to acquire drug assets at the end of Phase 2b and then design and execute pivotal clinical Phase 3’s utilizing their own clinical and regulatory infrastructure and commercial execution,” he explained. “Said another way, they look to acquire assets that represent high commercial potential at a Phase 2 price.”

Photo: Benzinga edit with photo by nfsstudi0 and Ground Picture on Shutterstock.

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