GH001 Phase 2b and 2a Clinical Trial Results in TRD and Bipolar II Disorder

GH Research PLC announced the acceptance of three clinical trial posters at the ACNP annual meeting. The posters detail positive results from Phase 2b trials of GH001 (synthetic mebufotenin) in treatment-resistant depression (TRD) and a Phase 2a trial in bipolar II disorder. Key findings include rapid and sustained antidepressant effects in TRD patients, with 57.5% achieving remission by Day 8 versus 0% placebo, maintained in 73% of patients at 6-month follow-up. GH001 demonstrated a favorable safety profile with no treatment-emergent suicidal behavior or intent, and only one transient suicidal ideation event. In bipolar II patients, GH001 showed 52.5% MADRS score reduction by Day 8 with 33.3% remission, no manic symptom induction, and mild-moderate adverse events. The trials highlight GH001's potential as a rapid-acting, scalable treatment with brief psychoactive effects (median 11 minutes) and infrequent retreatment needs. Data supports advancement to Phase 3 trials.