GHRS · GH Research PLC

Summary

GH Research PLC announced the peer-reviewed publication of Phase 2b trial results for GH001 (mebufotenin) in treatment-resistant depression in JAMA Psychiatry, confirming MADRS reduction of -15.5 points vs placebo on Day 8 (P<0.0001) and 57.5% Day 8 remission rate. A new post-hoc analysis shows efficacy independent of prior lifetime antidepressant failures, with Day 8 remission rates of 53.9%-63.6% across subgroups.

Key takeaways

• Phase 2b primary endpoint met: MADRS reduction -15.5 points vs placebo on Day 8 (P<0.0001)
• Day 8 remission rate 57.5% GH001 vs 0% placebo
• JAMA Psychiatry publication DOI: 10.1001/jamapsychiatry.2026.0096 includes full results and 6-month OLE data
• Post-hoc analysis: Day 8 remission 53.9%-63.6% for 2 to ≥5 prior failures (r=-0.13; P=0.44)
• Month 6 remission 61.5%-85.7% across subgroups
• Advancing GH001 to global pivotal trials