Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 166

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 166
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201 trial. In addition, this trial includes a 6-month open-label extension which is on track for completion of last patient visit in the first quarter of 2025. Advantages of GH001 TRD is our lead indication for the development of GH001. We believe that GH001, if approved, may provide significant benefits for patients with TRD. We aim to achieve the following goals:

| • | maximization of ultra-rapid and durable remissions; |

| • | single visit initial treatment, without additional mandated visits for psychotherapeutic intervention; and |

| • | convenient and infrequent re-treatment. |

Based on these features, we believe that GH001 has the potential to provide an attractive alternative to currently available therapies and other therapies in development for the treatment of TRD. Completed Clinical Trials with GH001 Phase 1 Trials: GH001-HV-101, GH001-HV-103, GH001-TRD-102 We have completed three Phase 1 clinical trials with GH001, our inhalable mebufotenin product candidate. Trial Design GH001-HV-101 (Healthy Volunteers) was designed in two parts: Part A was an open-label, single-arm, single-dose trial with four dose levels of GH001 being investigated and Part B was an open-label, single-arm, intra-subject dose escalation trial, where an IDR was administered on a single day with up to three increasing doses of GH001. GH001-HV-103 (Healthy Volunteers) was designed in two parts: a single-dose part, in a double-blind, placebo-controlled, randomized, parallel-group design with single, inhaled doses of GH001 or placebo in 3 dose groups of 10 subjects, whereby 8 subjects per dose group received GH001 and 2 subjects per dose group received a placebo; and a multiple-dose part, in an open-label, non-randomized design, where our IDR was administered on a single day with up to three increasing doses of GH001. GH001-TRD-102 (TRD Patients) was designed in two parts: Part A (n=8), which was an open-label, single-arm, single-dose Phase 1 trial with two dose levels of GH001 being investigated and Part B (n=8), which was an open-label, single-arm Phase 2 trial applying our IDR with intra-patient dose escalation with GH001. In each trial, GH001 was administered at a single visit without additional mandated visits for psychological intervention. 92