FDA Green Lights Ceruvia's Phase 2 Psilocybin Trial Program For Obsessive-Compulsive Disorder Treatment

Clinical-stage biopharma company Ceruvia Lifesciences recently received FDA  approval for its Investigational New Drug (IND) application for a Phase 2 clinical trial to determine the efficacy and safety of proprietary synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD). 

The company is focused on the development and commercialization of neurotransformational medicines for patients suffering from hard-to-treat headaches, OCD and substance abuse disorders. Based on a long history of partnership with leading researchers at Yale University School of Medicine, NYU School of Medicine and Harvard Medical School, Ceruvia is undertaking clinical research in order to help them return to living their lives to the fullest. 

The next Phase 2 clinical trial, set to begin in the second half of 2022, will be led by Dr. Benjamin Kelmedi and Dr. Christopher Pittenger of Yale's School of Medicine. The study would follow an undergoing pilot Phase 2 study taking place at the same institution, which has shown positive preliminary results. 

"With few effective treatment options available for the almost 4 million Americans who suffer from OCD, our Phase 2 clinical trial is an important step in helping these patients dramatically improve the quality of their lives," said Ceruvia's founder & CEO Carey Turnbull.

The multicenter, randomized, double-blind, active placebo-controlled clinical trial plans to enroll a total of 105 participants, who will receive 25mg of SYNP-101 or the active placebo, niacin. 

As stated by Ceruvia, the trial’s primary goal is to determine the reduction in obsessive-compulsive disorder symptoms for up to 12 weeks, after a single administration of SYNP-101. The treatment’s efficacy will be measured using the Yale-Brown Obsessive-Compulsive Scale, the most used and validated tool for assessing the clinical severity of OCD symptoms. 

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