Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 169

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 169
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 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 psychological intervention.The study enrolled 10 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. All TEAEs were mild or moderate. Results: Efficacy The primary endpoint of the Phase 2a proof-of-concept trial for GH001 in PPD was met with a significant reduction from baseline of –35.4 points (96.3%) in Montgomery–Åsberg Depression Rating Scale (MADRS) total score on Day 8 after administration of GH001 (p<0.0001). On Day 8, 100% of patients were in remission (MADRS ≤ 10). 95 Table of Contents GH001 led to an ultra-rapid antidepressant effect with a significant reduction in MADRS score at 2 hours after administration of –31.4 points (p<0.0001) and on Day 2 of –36.0 points (p<0.0001). Ongoing Clinical Trials with GH001 Phase 2b: Randomized, Double-Blind, Placebo-Controlled Clinical Trial with an Open-Label Extension of GH001 in Patients with TRD (GH001-TRD-201, NCT05800860) The open-label extension part of a multi-center, randomized, double-blind, placebo-controlled Phase 2b clinical trial of GH001 in patients with TRD is currently ongoing in Europe. The double blind part completed enrollment in Q3 2024. Trial Design The trial consists of two parts, as depicted below: Part 1, which is a 7-day randomized, double-blind, placebo-controlled phase, and Part 2, which is a 6-month open-label extension, or OLE, phase. The trial recruited 81 patients with TRD. In the double-blind part, 40 patients received GH001 and 41 received placebo, with all patients directly transitioning into Part 2 on Day 8. Patients were administered an individualized dosing regimen (IDR) of up to three escalating doses of GH001 or up to three doses of