The U.K. Medicines and Healthcare Regulatory Agency (MHRA) has green-lighted two separate Phase 3 trials conducted by Compass Pathways (NASDAQ: CMPS) for Treatment-Resistant Depression and Awakn Life Sciences (OTCMKTS: AWKNF) for Severe Alcohol Use Disorder (SAUD).
Details On Trials
Compass Pathways plc (NASDAQ: CMPS) will initiate the UK arm of its Phase 3 program on psilocybin therapy COMP360 for Treatment-Resistant Depression (TRD).
The ongoing program is reportedly the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. It consists of two pivotal trials, COMP 005 and COMP 006, each with an integrated long-term outcomes component.
Following the MHRA approval of the study, the multiple UK sites to participate in part of the company’s pivotal Phase 3 program include Compass’ newly-opened Centre for Mental Health Research and Innovation in London, where COMP 006 (assessing 25mg, 10mg and 1mg of COMP360) will take place.
Developed in partnership with South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology & Neuroscience at King’s …