Title: GH Research Provides Updates and Guidance on Treatment-Resistant Depression Clinical Development Program for GH001
Summary:
GH Research PLC, a clinical-stage biopharmaceutical company focused on psychiatric and neurological disorders, has provided updates on its clinical development program for GH001, its inhalable mebufotenin (5-MeO-DMT) product candidate for treatment-resistant depression (TRD). The company is currently conducting a European Phase 2b trial of GH001 and has submitted an Investigational New Drug Application for GH001 with the U.S. Food and Drug Administration (FDA). However, the FDA has placed the IND on clinical hold due to insufficient information to assess risks to human subjects. GH Research expects to resolve the FDA’s concerns and provide an update in November 2023.
Detailed Summary:
1. Introduction
– GH Research PLC provides updates and guidance on its clinical development program for GH001 in treatment-resistant depression.
– The company is focused on transforming the treatment of psychiatric and neurological disorders.
2. Development Strategy
– GH Research has completed a Phase 1/2 trial of GH001 in patients with TRD.
– The company is recruiting for a European Phase 2b trial of GH001 in patients with TRD.
– GH Research has submitted an Investigational New Drug Application (IND) for GH001 with the FDA.
3. Update on European Phase 2b Clinical Trial of GH001
– The Phase 2b trial has been approved in seven European countries and is expected to recruit approximately 80 patients across 20 sites.
– The primary objective is to determine the efficacy of GH001 compared with placebo in improving depressive symptoms.
– The trial includes a 7-day double-blind phase and a 6-month open-label extension phase.
4. Update on IND for GH001
– The FDA has placed the IND on clinical hold due to insufficient information to assess risks to human subjects.
– GH Research is awaiting a follow-up letter from the FDA and plans to provide an update in November 2023.
5. About GH Research PLC
– GH Research PLC is a clinical-stage biopharmaceutical company focused on psychiatric and neurological disorders.
– The company’s lead product candidate, GH001, is formulated for mebufotenin (5-MeO-DMT) administration via inhalation.
– GH001 has shown potential in treating TRD and is currently being evaluated in Phase 2b trials.
6. About GH002 and GH003
– GH002 and GH003 are additional product candidates formulated for mebufotenin (5-MeO-DMT) administration via intravenous and intranasal routes, respectively.
– GH002 is currently in Phase 1 clinical development, while GH003 is in preclinical development.
– GH Research aims to develop these candidates within the focus area of psychiatric and neurological disorders.
7. Forward-Looking Statements
– GH Research acknowledges that forward-looking statements in this press release are subject to risks and uncertainties and may differ from actual results due to various factors.
– The company disclaims any obligation to update these forward-looking statements unless required by applicable law.
