Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 168

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 168
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. All seven patients with a remission on Day 8 also achieved a MADRS clinical response, defined as a reduction of 50% or more from baseline in the MADRS total score. The mean MADRS change from baseline at Day 8, a secondary endpoint, was -24.4 (-76%). 94 Table of Contents Phase 2a: Clinical Trial with GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode (GH001-BD-202, NCT05839509) We have completed a Phase 2a clinical trial in Europe with GH001 in patients with BDII and a current major depressive episode. Trial Design The trial was designed as an open-label, non-randomized, single arm trial, where our IDR was administered on a single day with up to 3 increasing doses of GH001 (6 mg, 12 mg, 18 mg). GH001 was administered without additional mandated visits for psychological intervention.The study enrolled 6 patients of the planned 15 patients. The primary endpoint was to assess the effects on the severity of depression, as assessed by the mean change in MADRS from baseline to Day 8. Results: Safety All patients completed all planned visits. 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. Results: Efficacy The primary endpoint of the Phase 2a proof-of-concept trial for GH001 in BDII with a current major depressive episode was met with a significant reduction from baseline of –16.8 points (51.9%) in MADRS total score on Day 8 after administration of GH001 (p=0.0099). On Day 8, 33.3% of patients were in remission (MADRS ≤ 10). GH001 led to an ultra-rapid antidepressant effect with a reduction in MADRS score at 2 hours after administration of –16.3 points (p=0.0006) and on Day 2 of -13.3 points (p=0.0299). Phase 2a: Clinical Trial with GH001 in Female Patients with Postpartum Depression (GH001-PPD-203, NCT05804708) We have completed a Phase 2a clinical trial in Europe with GH001 in female patients with PPD. Trial Design The trial was designed as an open-label, non-randomized, single