Ceruvia Lifesciences’ Investigational New Drug (IND) Application for a Phase II clinical trial of synthetic psilocybin (SYNP-101) to treat obsessive-compulsive disorder (OCD) received clearance from the US Food and Drug Administration (FDA).
Following a positive pre-IND meeting with the regulatory agency, the company filed an application seeking IND approval in May this year to commence the Phase II trial.
The randomised, multicentre, double-blind, active placebo-controlled trial will analyse the safety and efficacy of SYNP-101 to treat OCD symptoms.
The trial anticipates enrolling 105 subjects, who will be given a 25mg dose of SYNP-101 or the active placebo, niaicin.
Analysing the decline in OCD symptoms for up to 12 weeks following a single dose of SYNP-101 is the trial’s primary endpoint.
The efficacy of the therapy will be assessed using the Yale-Brown Obsessive Compulsive Scale, an established tool to evaluate OCD symptoms’ clinical severity.
The trial is expected to start in the second half of this year.
According to initial data from a Ceruvia-funded pilot Phase II study at Yale School of Medicine, psilocybin showed to offer quick and strong improvement in OCD symptoms with a lasting effect.
Ceruvia Lifesciences founder and CEO Carey Turnbull said: “With positive preliminary results from a Ceruvia-funded pilot Phase II study taking place at Yale School of Medicine, we are excited to have received FDA approval to begin our Phase II clinical trial to examine the efficacy and safety of psilocybin in treating OCD.
“With few effective treatment options available for the almost four million Americans who suffer from OCD, our Phase II clinical trial is an important step in helping these patients dramatically improve the quality of their lives.”