Business
GH Research Provides Business Updates and Highlights Key Upcoming Milestones
Initial approvals received for Phase 2b trial of GH001 in TRD (GH001-TRD-201), initiation of this trial expected in Q1 2023Development of proprietary aerosol
About this update from Gh Research Plc
[{"type":"text","content":"Initial approvals received for Phase 2b trial of GH001 in TRD (GH001-TRD-201), initiation of this trial expected in Q1 2023Development of proprietary aerosol delivery device for GH001 progressed, IND submission with this device expected in Q3 2023Phase 1 trial of GH002 in healthy volunteers (GH002-HV-105) initiated, completion of this trial expected in Q4 2023New patent application filed, expanding patent portfolio to 11 familiesMebufotenin selected by WHO as International Nonproprietary Name for 5-MeO-DMT DUBLIN, Ireland, Jan. 09, 2023 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today provided updates on its business and highlighted key upcoming milestones. GH001 for the treatment of TRD GH001 is our proprietary inhalable mebufotenin (5-MeO-DMT) product candidate. We have recently received initial regulatory and ethical approvals for our planned multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). We continue to expect initiation of this trial in several European countries in the first quarter of 2023. Trial design details are described in our updated corporate presentation, which is available in the investor section on our website. Proprietary aerosol delivery device for GH001 In 2021, we initiated the development of a proprietary aerosol delivery device for GH001 for use in our pivotal clinical trial program and for commercial use. Based on recent development progress, we now expect to submit an IND for GH001, delivered with this proprietary device, in the third quarter of 2023. The IND-opening study will be a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-106), designed to support bridging to the clinical data generated with the third-party device we currently use in our clinical trials. Due to the progress with our proprietary aerosol delivery device, we no longer plan to submit an IND with this third-party device. GH002 GH002 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary injectable approach. The previously announced randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002 in healthy volunteers (GH...