Biopharma firm Ceruvia Lifesciences is to carry out a clinical trial of synthetic psilocybin as a potential treatment for obsessive-compulsive disorder (OCD).
The company, which develops “neurotransformational medicine” has submitted an application to begin a phase 2, multi-centre, randomised, double blind, active placebo controlled clinical trial to to determine the efficacy and safety of synthetic psilocybin.
Researchers will trial a single oral dose to treat OCD symptoms up to 12 weeks after dosing.
The trial will be initiated in the second half of this year, led by principal investigators Dr. Benjamin Kelmedi and Dr. Christopher Pittenger of Yale University School of Medicine.
Carey Turnbull, CEO of Ceruvia Lifesciences, said: “This IND application represents an important milestone in our efforts to develop neurotransformational medicines for underserved patient populations. With few effective treatment options available, we believe that psilocybin has the potential to play a critical role in improving patient quality of life for those suffering from OCD.”
Currently treatment options for OCD are largely limited to cognitive-behavioural therapy and anti-depressants. For many patients, these treatments, even in combination, are ineffective and the use of antidepressants results in unpleasant side-effects.
The unique properties of the classic psychedelic psilocybin, may offer a significant improvement in safety and efficacy over currently available treatments for OCD.
“Building on the positive preliminary results of the ongoing pilot Phase 2 study, our Phase 2 trial will provide critical data on the efficacy and safety of psilocybin in producing clinically meaningful and sustained reductions in OCD symptoms” says Judy Ashworth, acting chief medical officer, Ceruvia Lifesciences.
“With this IND application we are taking an important step in advancing our drug development pipeline and clinical research programme.”
Founded in 2017, Ceruvia Lifesciences is a clinical-stage biopharma company which aims to improve the lives of underserved patients suffering from neurological and psychiatric disorders.
