Braxia Scientific has dosed the first patients in its multi-dose psilocybin clinical trial exploring the compound’s efficacy for treatment-resistant depression (TRD).
Medical research company Briaxia Scientific has commenced dosing of patients enrolled in its landmark trial.
Conducted at the company’s subsidiary Canadian Rapid Treatment Center of Excellence (CRTCE ) clinic, the trial establishes psilocybin treatment framework for patients with TRD and opens new pathway for patients to access psychedelic treatment.
CEO, Dr Roger McIntyre, commented: “This is a historically significant occasion for our patients, for Braxia, and for other organisations that endeavour to discover and develop innovative rapid-acting psychedelic treatments for the mental health sector.
“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.
“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.
“Second, our proprietary data from this landmark trial will enable us to continue our work developing potential new chemic al entities in the future, while providing patients with TRD immediate access to new treatment.”
The trial is being sponsored by the Brain and Cognition Discovery Foundation, and includes adults with TRD as part of bipolar or unipolar disorder, who have not benefited from multiple conventional treatments.
CMO, Dr Joshua Rosenblat, principal investigator of the trial, added: “Outside of rare exemptions for a very small number of patients with terminal medical illnesses, the only way to legally access psilocybin treatment in Canada is through Health Canada-approved clinical trials.
“As we have the country’s only open trial (e.g., 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.”
The company has established access to a high-quality source of psilocybin that meets all regulatory requirements for human use in clinical research and received Health Canada and Research Ethics approval for protocols to collect treatment outcome data, allowing for further optimisation of psilocybin treatment protocols and development of best practice guidelines.
Additionally, it has trained medical and research staff who provide psilocybin-assisted therapy with high quality safety monitoring, and it has developed physical space to safely provide the treatment with appropriate medical and psychological monitoring and protocols.
Rosenblat continued: ”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, Braxia Scientific is positioned to immediately provide access to psilocybin-assisted therapy treatment for eligible patients.”
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