Braxia Scientific Corp has said that its clinical research and development team will commence a randomized clinical trial (RCT) targeting treatment-resistant depression using psilocybin.
The Toronto-based company said the trial is the latest step as it develops the next generation of novel psychedelic treatments and delivery systems through its network of clinics.
The study will demonstrate that it can effectively conduct a randomized controlled trial using psychedelic-assisted therapy. This will enable it to build the infrastructure for future studies and future clinical care, while also compiling efficacy data and providing the opportunity to evaluate a therapist training program launched at the end of June 2021, Braxia said.
"This will be the broadest study of its kind," the trial's principal investigator and medical director of the Canadian Rapid Treatment Centre of Excellence (CRTCE) Dr Joshua Rosenblat said in a statement.
"Whereas most other treatment-resistant depression (TRD) studies limit participation to patients that have not found relief from a maximum of five other potential remedies, our research will not have an upper limit, and will even include patients that have endured dozens of unsuccessful medical trials, including ketamine and electroconvulsive therapy,” he added.
The CRTCE is a wholly-owned subsidiary of Braxia.
By including everyone with more than two failed medical trials, Braxia said it will increase the degree to which the results can be applied to a larger population, making its findings much stronger. Furthermore, it will have fewer exclusion criteria and will even include patients with bipolar depression – a huge first for the field – or comorbid disorders, which were excluded in psilocybin studies done by other companies, the company added.
"Integrating psilocybin provides immense opportunity for the benefit of those dealing with treatment-resistant depression,” Braxia CEO Dr. Roger McIntyre said.
“Unfortunately, over one-third of the more than 300 million people suffering with depression worldwide fail to adequately respond to currently approved treatments, and thus the TRD market is very large and disproportionately dominates the majority of mental health services."
In a separate statement, Braxia said it has been served with a class action complaint against the company, its former CEO and president, for the violation of US federal securities laws.
The complaint was filed in the US District Court Central District of California and alleges that the company and the individual defendants violated ss. 10(b) and 20(a) of the Securities and Exchange Act of 1934 and Rule 10b-5 promulgated thereunder.
The claim is based on allegations relating to the company's disclosure documents regarding four acquisitions made in 2020 and related matters. The plaintiff is seeking an unspecified amount of damages for the proposed class.
The company said it intends to vigorously defend the action.
Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders.
Contact the author at stephen.gunnion@proactiveinvestors.com