GH Research Publishes Phase 2a Trial Results for Postpartum Depression

GH Research announced the publication of the full results from its Phase 2a trial in postpartum depression and the acceptance of two oral presentations at the 37th World Congress of Neuropsychopharmacology. The peer-reviewed article, titled "Inhaled Mebufotenin for Adult Patients with Postpartum Depression: A Phase 2a Open-Label Clinical Trial," has been published in The Journal of Clinical Psychiatry. The article reports the full results from the Phase 2a, single-arm, open-label trial, which enrolled 10 adult women with PPD. Key resultsL Primary endpoint met: Mean Montgomery-Asberg Depression Rating Scale reduction of -35.4 points from baseline to Day 8; 100% of patients achieved remission within two hours of dosing, sustained through Day 8; Improved maternal functioning: Mean 34.1-point increase on the Barkin Index of Maternal Functioning at Day 8; Well-tolerated: No serious adverse events; all treatment-emergent adverse events mild or moderate; no treatment-emergent suicidal ideation or behavior; An analysis of breast milk supports a treatment strategy with only a brief interruption of breastfeeding around GH001 dosing "To our knowledge, this is the first published clinical trial of a psychedelic-based therapeutic specifically in postpartum depression, and the rapid remission achieved by all patients within hours of a single-day inhaled treatment, sustained through Day 8 with a favorable safety profile and only brief interruption of breastfeeding, is encouraging for a population that needs additional rapid-acting therapeutic options. These findings support further investigation of inhaled mebufotenin in larger, randomized, placebo-controlled trials in postpartum depression," said Kristina M. Deligiannidis, MD, of the Feinstein Institutes for Medical Research at Northwell Health.