Biotechnology company Compass Pathways plc (Nasdaq: CMPS) announced on Wednesday that it has completed recruitment for its Phase 3 COMP005 trial investigating COMP360 psilocybin in treatment-resistant depression (TRD). Screening is now closed, with final participants undergoing pre-dosing procedures.
Top-line results for the trial's 6-week primary endpoint remain on track for late Q2 2025, with 26-week data expected following the completion of the COMP006 trial in the second half of 2026.
COMP360 is a synthetic psilocybin formulation designed for use with psychological support. The trial is the largest randomized, controlled, double-blind psilocybin study ever conducted.
Compass Pathways is focused on accelerating access to evidence-based innovations in mental health. COMP360 has received Breakthrough Therapy designation from the FDA and ILAP designation in the UK for TRD.
Yingli Pharma's linperlisib Phase 3 registration study approved by US FDA
Organon acquires US rights to TOFIDENCE from Biogen
Oncopeptides secures FDA approval to resume OPD5 clinical development
Bonesupport submits FDA application for CERAMENT V
Spinogenix starts enrolment for SPG302 Phase 2 trial in schizophrenia
DDL opens new GMP laboratory for drug-device combination product testing
Langhua Pharmaceutical passes US FDA's on-site inspection
PTC Therapeutics announces opinion regarding Translarna's (ataluren) European renewal authorisation