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GH Research provides business updates, key upcoming milestones
The Fly

GH Research provides business updates, key upcoming milestones

GH Research provided updates on its business and highlighted key upcoming milestones. GH001 for the treatment of TRD: "GH001 is our proprietary inhalable mebufotenin 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. We continue to expect initiation of this trial in several European countries in the first quarter of 2023," the company said. 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, 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," the company said. GH002: "GH002 is our mebufotenin 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 has recently been initiated. We expect to complete this trial in the fourth quarter of 2023," the company said. Intellectual property: "We have recently filed a new device-related patent application, expanding our patent portfolio to 11 patent families, that relate to various aspects of mebufotenin use in a therapeutic context, including but not limited to the use of mebufotenin for treatment of various disorders when administered by inhalation, or by nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes," the company said. Other updates: "We are pleased to announce the selection of mebufotenin as the International Nonproprietary Name for 5-MeO-DMT by the World Health Organization Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. From this point forward, we will introduce the nomenclature mebufotenin into our communications."

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