Braxia Scientific Corp announced that preliminary results from a Phase 2 clinical trial of multi-dose psilocybin-assisted therapy for treatment-resistant depression showed clinically meaningful movements in depression severity.
Braxia Scientific's ongoing multi-dose psilocybin trial effectively demonstrated the feasibility of its proprietary psilocybin-assisted therapy protocol with high rates of recruitment and retention with adequate tolerability and safety, the company said.
Specifically, 93% of patients were retained to the primary endpoint, where there have been no serious adverse events and suicide attempts to date, and the majority of adverse effects were resolved within 24 hours of each dose. Some 87% of the participants requested to receive a second dose.
READ: Braxia Scientific receives Health Canada approval to provide psilocybin-assisted therapy to a patient with major depressive disorder
The trial is the first approved by Health Canada to evaluate the feasibility, safety, tolerability, and efficacy of multi-dose psilocybin-assisted therapy for this purpose, the company said. The preliminary results were presented at the From Research to Reality Conference in Toronto last week.
Depression severity is being measured using MADRS (Montgomery-Asberg Depression Rating Scale), with complete analysis of antidepressant efficacy and secondary outcomes pending.
This trial will be completed by December, at which point the full analysis will be completed and submitted for publication, the company said.
"These results clearly show that we have the infrastructure, expertise and personnel to effectively and safely provide psilocybin-assisted therapy,” Braxia Scientific's Chief Medical and Scientific Officer Joshua Rosenblat said in a statement.
"While these preliminary results are highly encouraging, they also provide us with additional guidance as we evaluate and optimize our clinical protocols in delivering innovative, psychedelic treatments to patients with treatment resistant depression. These results also reinforce the potential value of the clinical infrastructure we have established to target new innovative treatments."
Braxia Scientific was the first to receive Health Canada approval for a multi-dose psilocybin-assisted therapy clinical trial in July 2021, and dosed its first participant in November 2021, the company said. This ongoing clinical trial provides Canadians with immediate access to psilocybin for treatment-resistant depression.
"In addition to our ongoing trial that enables us to provide access to this treatment today, we are excited by the prospect these results with psilocybin may offer patients with treatment-resistant depression, an area in need of therapeutic innovation,” CEO Roger McIntyre said.
“In addition to guiding professionals internationally on the safe and effective implementation of ketamine, Braxia Scientific is also conducting highly rigorous clinical research with psilocybin, ketamine, and related agents with the aim to provide eligible persons with innovative treatments that work rapidly and are safe to administer," he added.
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