Compass Pathways (Nasdaq: CMPS), a biotech company in the psychedelics space, announced it has completed a key milestone on its path to obtaining FDA approval for psilocybin in the treatment of depression.
The company reported that it had completed psilocybin administration to all 216 patients that were targeted for Compass’ phase IIb clinical trial for treatment-resistant depression.
The trial, which is using a proprietary version of isolated psilocybin known as COMP360, is the world’s largest psilocybin therapy trial to date and could lead the company toward securing five to seven years of market exclusivity for psilocybin treatment in the U.S., if it is approved.
The study is looking at the safety and efficacy of psilocybin therapy, administering different doses of psilocybin in conjunction with psychological support from trained therapists. Enrollment for the trial has been closed and an additional 14 patients will receive psilocybin therapy before July 8, completing the administration.
Patients will be monitored for 12 weeks after their session. The company expects to report data from the trial before the end of this year.
“We are fortunate to be doing this in collaboration with hundreds of talented and dedicated people from our 22 trial sites in 10 countries - including investigators, raters, study coordinators and nurses, therapists, and pharmacists – as well as our supply chain and clinical research partners,” said George Goldsmith, CEO and co-founder of Compass.
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