GH Research announces publication of Phase 2b results for mebufotenin

GH Research (GHRS) announced two peer-reviewed publications from its Phase 2b clinical program of GH001 in treatment-resistant depression: the primary trial results in JAMA Psychiatry, and a new analysis demonstrating that efficacy is independent of the number of prior lifetime treatment failures in a forthcoming issue of Psychopharmacology Bulletin. The peer-reviewed article, titled “GH001 vs Placebo in Patients with Treatment-Resistant Depression” has been published today in JAMA Psychiatry. The publication includes the complete results from the randomized, double-blind, placebo-controlled Phase 2b trial of mebufotenin in patients with TRD, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from the 6-month open-label extension. These results were previously reported in topline form. A supporting peer-reviewed article, titled “GH001 Efficacy is Independent of Prior Antidepressant Treatment Failures in Treatment-Resistant Depression: A Post Hoc Analysis of a Phase 2b Randomized Controlled Trial,” will be published in a forthcoming issue of Psychopharmacology Bulletin. In TRD, a well-established finding across multiple treatment modalities is that remission rates decline significantly with each successive antidepressant treatment failure. This pattern, first quantified in the landmark STAR*D trial, represents a fundamental challenge in treating patients with extensive treatment histories. The new analysis of Phase 2b data demonstrates that GH001 does not follow this pattern: Day 8 remission rates ranged from 53.9% to 63.6% across patients with 2 to greater than or equal to5 prior lifetime antidepressant failures, with no decline at higher failure counts; End of trial/Month 6 remission rates ranged from 61.5% to 85.7% across the same subgroups; and No meaningful correlation was observed between the number of prior lifetime treatment failures and Montgomery-Asberg Depression Rating Scale improvement at Day 8 or among those who completed the 6-month OLE. “One interesting, unanticipated finding from this trial is that the benefit of GH001 appeared to be independent of the number of prior lifetime antidepressant failures. Remission rates were consistently high across subgroups – in contrast to the decline seen with each successive treatment that we observed in the STAR*D trial. This suggests patients who have not responded to three or more prior courses of antidepressant therapy might benefit from this novel therapy,” said MichaelThase, MD, Professor of Psychiatry, Perelman School of Medicine at the University of Pennsylvania.