Primary Endpoint Met in GH Research’s Phase 2b GH001Trial in TRD

February 3, 2025

DENVER, Colo., Feb 03, 2025 (247marketnews.com)- GH Research (NASDAQ:GHRS) announced that its Phase 2b clinical trial of GH001, an inhalable mebufotenin product, for treatment-resistant depression (TRD) met its primary endpoint. The trial involved 81 patients, with 40 receiving GH001 and 41 receiving a placebo. Results showed a significant reduction in depression symptoms, with a -15.2 point decrease in the Montgomery-Åsberg Depression Rating Scale (MADRS) score for GH001 patients compared to a +0.3 point increase for the placebo group (p<0.0001).

All secondary endpoints were also met, showing improvements in other depression measures. GH001 was well tolerated, with no serious adverse events or significant safety concerns. The treatment led to rapid improvements, and most patients were discharge-ready within 1 hour after treatment. Follow-up data from an ongoing extension phase (OLE) indicated that 77.8% of patients who completed the OLE were in remission after six months.

Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, University of Pennsylvania, stated, “Patients treated with GH001 experienced a difference of -15.5 points in MADRS score at Day 8 compared to placebo, which is truly remarkable. Most TRD patients have not benefited from a number of established treatment options and this illness frequently imposes years of insurmountable mental suffering and disabling effects on social and vocational functioning. A novel treatment with such a large and rapid effect, particularly one that may require only infrequent, short 1-3 hours clinic visits, has the potential to be a practice changing treatment.”

Dr. Villy Valcheva, GH Research’s CEO, added, “Today, as we share our unprecedented positive Phase 2b data, we celebrate a significant milestone in our journey to interventional psychiatry and pave the way for our future commercial success with GH001 in treatment-resistant depression. The ultra-rapid and profound reduction in depressive symptoms, coupled with sustained remission through infrequent, short treatment visits, positions us uniquely.”

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