Braxia Scientific Corp, a medical research company with clinics providing novel psychedelic treatments for depression, revealed that it has hit a milestone by running the first Health Canada-approved multiple-dose psilocybin clinical trial which started with the first patients dosed in November this year.
The trial, sponsored by the Brain and Cognition Discovery Foundation, is being conducted at the Canadian Rapid Treatment Center of Excellence (CRTCE), which is a wholly-owned subsidiary of Braxia.
Braxia said the trial includes adults with treatment-resistant depression (TRD) as part of bipolar or unipolar disorder, who have not benefited from multiple treatments. This study is the only Health Canada-approved psilocybin trial in Canada that is actively recruiting participants at this time.
Of the more than 300 million people suffering from depression worldwide, it is estimated that up to two-thirds of affected people receiving treatment will inadequately respond to currently approved treatments, making patients with TRD a very large population that disproportionately dominates the majority of mental health services.
"This is a historically significant occasion for our patients, for Braxia, and for other organizations that endeavour to discover and develop innovative rapid-acting psychedelic treatments for the mental health sector," Braxia Scientific CEO Dr Roger McIntyre said in a statement.
"For patients who have undergone at least two – and possibly dozens of – unsuccessful conventional treatments for their depression, this remedy offers a potential and innovative treatment avenue for adults with TRD."
Dr McIntyre noted that for Braxia Scientific, it marks two very important milestones.
“First, this trial establishes a proprietary framework and positions our platform among the leading groups that endeavour to research and develop new psychedelic treatments for TRD,” said Dr McIntyre. “Second, our proprietary data from this landmark trial will enable us to continue our work developing potential new chemical entities in the future, while providing patients with TRD immediate access to a new treatment."
Braxia Chief Medical and Scientific Officer Dr Joshua Rosenblat, who is also the principal investigator of the trial, said that outside of rare exemptions for patients with a terminal illness, the only way to legally access psilocybin treatment in Canada is through clinical trials.
“As we have the country's only open trial (only one actively recruiting, enrolling, and treating participants with psilocybin), the CRTCE is currently the only place in Canada that can legally provide psilocybin for depression in the absence of any comorbid medical condition," said Dr Rosenblat.
Braxia said it has grown its infrastructure to provide novel interventions that include ketamine, psilocybin, and other potential future psychedelics that become available in the following way:
- Established access to a high-quality source of psilocybin that meets regulatory requirements for use in clinical research;
- Received over 150 referrals to date for psilocybin-assisted therapy for treatment-resistant depression at its clinic in the first six weeks of opening recruitment;
- It has received Health Canada and Research Ethics approval for protocols to collect treatment outcome data to develop best practice guidelines;
- Trained medical and research staff as part of Braxia Institute will provide psilocybin-assisted therapy with high-quality safety monitoring. All the therapists were trained by the Braxia Institute and are serving as study therapists for the active psilocybin clinical trial;
- Developed physical space to safely provide psilocybin treatment with a comfortable living room-like environment with appropriate medical and psychological monitoring and protocols.
"This tremendous infrastructure enables Braxia Scientific to provide psilocybin-assisted therapy today, as part of the current clinical trial, and importantly if psilocybin is approved in the future for use outside of clinical trials,” said Dr Rosenblat.
The trial will allow Braxia to evaluate the psilocybin-assisted therapy training program it launched earlier this year. Once the psilocybin study is done, the Braxia Institute will graduate the first cohort of medical professionals, a multidisciplinary group of 20 therapists from diverse psychiatry and psychotherapy backgrounds.
Braxia operates multidisciplinary community-based clinics offering rapid-acting treatments for depression in Mississauga, Toronto, Ottawa, and Montreal.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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