Title: GH Research Provides Updates and Guidance on Clinical Development Program for GH001 in Treatment-Resistant Depression
Summary:
GH Research PLC, a clinical-stage biopharmaceutical company, has provided updates and guidance on its clinical development program for GH001, an inhalable mebufotenin (5-MeO-DMT) product candidate, in the treatment of patients with treatment-resistant depression (TRD). The company is currently recruiting for a Phase 2b trial in Europe and has submitted an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA). However, the FDA has placed the IND on clinical hold pending further information.
1. Development Strategy
– Completion of Phase 1/2 trial in TRD patients (GH001-TRD-102)
– Recruitment for Phase 2b trial in TRD patients (GH001-TRD-201)
– Submission of IND for Phase 1 healthy volunteer trial (GH001-HV-106)
2. Update and Guidance on European Phase 2b Clinical Trial
– Approval in seven European countries
– Expected recruitment of 80 patients across 20 sites
– Primary objective is to determine the efficacy of GH001 compared to placebo
– Double-blind phase expected to be completed in Q3 2024, with top-line data available in Q3 or Q4 2024
3. Update on IND for GH001
– IND placed on clinical hold by FDA due to insufficient information to assess risks
– Awaiting follow-up letter from FDA and plan to provide an update in November 2023
4. About GH Research PLC
– Clinical-stage biopharmaceutical company focused on psychiatric and neurological disorders
– Lead product candidate GH001 formulated for mebufotenin (5-MeO-DMT) administration via inhalation
– Beyond TRD, GH Research is exploring GH001 for bipolar II disorder and postpartum depression
– Two other product candidates, GH002 and GH003, being developed for various indications
Note: This summary is based on the information provided in the press release and may not include all details.
