(RTTNews) - GH Research PLC (GHRS), a clinical-stage biopharmaceutical company, on Thursday announced Phase 2a results for GH001 in treating post-partum depression (PPD). Results were published in The Journal of Clinical Psychiatry.
The company's lead candidate GH001 contains mebufotenin formulated via a proprietary inhalation approach.
The Phase 2b GH001-TRD-201 trial was a single-arm, open-label study with 10 enrolled PPD patients. The primary endpoint was set at a reduction in depression measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
Results indicate that the primary endpoint was met, with patients showing a mean MADRS reduction of 35.4 points from the baseline to Day 8. Additionally, 100% of patients achieved remission (MADRS less than 10) within two hours of dosing. An improvement in maternal functioning was also noted, with a mean 34.1-point increase on the Barkin Index of Maternal Functioning by Day 8. The drug was found to be well-tolerated.
The company stated that the results supported further investigation of inhaled mebufotenin in larger, randomized, placebo-controlled trials in PPD.
GH001 is being advanced in the studies for treatment-resistant depression (TRD).
GHRS closed Thursday at $23.25, down 4.83%.
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