GH Research Advances Clinical Development for GH001 in Treatment-Resistant Depression

In a recent press release, GH Research PLC GHRS announced key developments and future plans for their clinical program surrounding GH001, their novel therapeutic for treatment-resistant depression (TRD). GH Research, a leader in biopharmaceutical innovation, is focused on revolutionizing the management of psychiatric and neurological conditions.

Clinical Development Strategy for GH001

The company had previously publicized positive outcomes from their Phase 1/2 trial of GH001 in TRD patients (GH001-TRD-102). Progressing from this success, they are now advancing to a multi-center Phase 2b trial within Europe (GH001-TRD-201). This randomized, double-blind, placebo-controlled study, which will involve recruiting approximately 80 patients across 20 sites, employs an externally-sourced inhalation device for administration of GH001.

In conjunction with these European endeavors, an IND application for GH001 was submitted to the U.S. FDA for approval to commence a Phase 1 clinical trial involving healthy volunteers (GH001-HV-106). This trial is intended to verify the comparable efficacy of GH001 when administered using the company’s proprietary aerosol delivery device, setting the stage for a pivotal global Phase 3 program.

Advancements in European Phase 2b Clinical Trial for TRD

The company's Phase 2b study has seen substantial advancements with approvals from seven European nations. The trial aims to ascertain the effectiveness of a single-day individualized dosing regimen (IDR) of GH001 against placebo. Upon completion of the trial's 7-day double-blind phase, all participants will have the opportunity to receive the GH001 IDR treatment during a 6-month open-label phase. Recruitment and site initiations are on track, and completion of the double-blind phase is expected in Q3 2024, with top-line data anticipated in late 2024.

FDA IND Submission Update

The FDA submission for GH001 has encountered a temporary setback, with the agency placing the IND on clinical hold for reasons related to insufficient information to assess subject risk. GH Research plans to address the FDA's concerns promptly upon receipt of a detailed follow-up letter, projected to arrive within 30 days from the notification. A progress report is expected in the upcoming earnings release in November 2023.

About GH Research PLC and GH001

GH Research PLC prides itself on its mission to transform treatments for challenging psychiatric and neurological disorders. It's lead candidate, GH001, leverages the psychoactive compound mebufotenin (5-MeO-DMT) through an inhalable formulation, demonstrating a significant potential in treating TRD, as seen in early clinical trials.

The company's ongoing initiatives also include Phase 2a proof-of-concept trials for bipolar II depression and postpartum depression, along with the continued development of other delivery methods such as GH002 (intravenous) and GH003 (intranasal), aimed at specific niche demographics within their target disorders.

Concluding the release, GH Research underscores its commitment to navigating the regulatory path ahead and fulfilling its promise to bring innovative treatments to patients in need. As the clinical trials evolve, the biopharmaceutical community and investors alike keenly await results that could herald a new chapter in the management of treatment-resistant depression.

biopharmaceutical, depression, clinical