GH Research announces primary endpoint met in two Phase 2a PoC trials

GH Research (GHRS) provided updates on its business and highlighted key upcoming milestones. Primary Endpoint Met in Phase 2a Proof-of-Concept Trial in PPD The primary endpoint of the Phase 2a proof-of-concept trial for GH001 in postpartum depression was met with a significant reduction from baseline of -35.4 points in Montgomery-Asberg Depression Rating Scale total score on Day 8 after administration of GH001. On Day 8, 100% of patients were in remission. GH001 led to an ultra-rapid antidepressant effect with a significant reduction in MADRS score at 2 hours after administration of -31.4 points and on Day 2 of -36.0 points. The trial recruited 10 patients with PPD. All patients were administered an individualized dosing regimen of up to three escalating doses of GH001. There was no psychotherapeutic intervention in this trial. The mean total MADRS score on Day 8 was 1.3 and all 10 patients were in remission. GH001 was well tolerated and no treatment-related serious adverse events were reported. All treatment-emergent adverse events were mild or moderate. Primary Endpoint Met in Phase 2a Proof-of-Concept Trial in BDII: The primary endpoint of the Phase 2a POC trial for GH001 in bipolar II disorder with a current major depressive episode was met with a significant reduction from baseline of -16.8 points in MADRS total score on Day 8 after administration of GH001. On Day 8, 33.3% of patients were in remission. GH001 led to an ultra-rapid antidepressant effect with a reduction in MADRS score at 2 hours after administration of -16.3 points and on Day 2 of -13.3 points. The trial recruited 6 patients with BDII. All patients were administered an IDR of up to three escalating doses of GH001. There was no psychotherapeutic intervention in this trial. GH001 was well tolerated and no treatment-related serious adverse events were reported. The majority of TEAEs were mild or moderate and there were no reported TEAEs of hypomania or mania.