Ceruvia Lifesciences, a US-based neurotransformational medicine biopharmaceutical company, announced on Monday that it has received approval from the United States Food and Drug Administration (FDA) for its Investigational New Drug application for a Phase two clinical trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD).
The company's phase two, multicentre, randomised, double blind, active placebo controlled clinical trial is intended to assess the safety and efficacy of synthetic psilocybin (SYNP-101) to treat patients with OCD symptoms.
The trial is to enrol a total of 105 subjects, who will receive 25mg of SYNP-101 or the active placebo, niaicin. The primary endpoint of the trial is to determine the decrease in OCD symptoms for up to 12 weeks after a single administration of SYNP-101. Efficacy of treatment will be evaluated utilising the Yale-Brown Obsessive Compulsive Scale. The trial is to start in the second half of 2022 and will be headed by principal investigators Dr Benjamin Kelmedi and Dr Christopher Pittenger of Yale University School of Medicine.
GSK releases decade-long data on Shingrix efficacy
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients