(RTTNews) – GH Research PLC (GHRS), a clinical‑stage biopharmaceutical company, announced on Thursday that its Phase 2a trial of GH001 met the primary endpoint for treating post‑partum depression (PPD). The findings were published in The Journal of Clinical Psychiatry.
GH001 is a mebufotenin formulation delivered through the company’s proprietary inhalation platform.
The Phase 2b GH001‑TRD‑201 study was a single‑arm, open‑label trial enrolling ten patients with PPD. The primary endpoint required a reduction in depressive symptoms measured by the Montgomery‑Åsberg Depression Rating Scale (MADRS).
Results showed that the primary endpoint was achieved, with participants experiencing an average MADRS reduction of 35.4 points from baseline to Day 8. All patients reached remission (MADRS < 10) within two hours of dosing. Maternal functioning also improved, with a mean increase of 34.1 points on the Barkin Index of Maternal Functioning by Day 8. The treatment was well tolerated.
The company said the data support further evaluation of inhaled mebufotenin in larger, randomized, placebo‑controlled trials for PPD.
GH001 is also being advanced in studies targeting treatment‑resistant depression (TRD).
GHRS closed Thursday at $23.25, down 4.83%.
The views and opinions expressed herein are those of the author and do not necessarily reflect those of Nasdaq, Inc.
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