GH Research Announces Clinical Progress and Path Forward for GH001 in the Battle Against Treatment-Resistant Depression

DUBLIN, Ireland, Sept. 29, 2023 -- GH Research PLC GHRS, a forward-thinking biopharmaceutical entity, is actively innovating within the realms of psychiatric and neurological disorders. The latest communication from the company delivers insightful updates to the clinical pathway of GH001, their inhaled 5-MeO-DMT candidate, in addressing the need for novel treatments in treatment-resistant depression (TRD).

Evolution of the Development Strategy

Following the positive outcomes of their Phase 1/2 trial (GH001-TRD-102), GHRS has been steadfast in progressing with a Phase 2b trial (GH001-TRD-201) staged across multiple European centers. This randomized, double-blind, placebo-controlled trial employs a meticulously sourced external inhalation device to administer GH001. Alongside these European trials, GHRS has also endeavored to extend its research footprint by filing an Investigational New Drug Application (IND) with the FDA to initiate a Phase 1 pharmacology trial in healthy volunteers using their proprietary aerosol delivery device (GH001-HV-106). The goal is to merge the data from diverse devices to propel a global Phase 3 program.

Insights and Expectations for the European Phase 2b Trial

The company's continuing Phase 2b trial aims to recruit around 80 participants across likely 20 sites, with a vision to quantify the antidepressant efficacy of GH001 via mean changes in the Montgomery-Åsberg Depression Rating Scale (MADRS). Inching closer to completion with 14 sites operational and more in the pipeline, the double-blind phase is projected to conclude in the third quarter of 2024, with anticipation for the ensuing data later the same year.

FDA IND Submission and Clinical Hold

GHRS's journey, however, has encountered certain regulatory resistance. The FDA's clinical hold on the GH001 IND cites a need for heightened clarity to evaluate risks. The FDA has promised a detailed follow-up, which GHRS awaits to provide a clearer roadmap and eagerly anticipates resuming productive dialogue in their November 2023 earnings release.

About GH Research PLC's Innovative Edge

GHRS stands at the forefront of therapeutic innovation, with GH001 steering their voyage into new paradigms of care for those with TRD. This pursuit is supported by two Phase 1 healthy volunteer trials and a successful Phase 1/2 trial, showcasing GH001's potential for rapid remission in TRD cases. Beyond GH001, GHRS nurtures GH002 and GH003—alternative 5-MeO-DMT formulations aimed at intravenous and intranasal administration respectively, each carving their own specialized niches within the broad spectrum of mental health disorders.

Looking Towards the Future

As GHRS forges ahead, they carry with them a host of forward-looking aspirations and commitments. Understanding the unpredictability of scientific and regulatory landscapes, they take forward strides with prudence, focusing on collaborative problem-solving with regulatory bodies and diligently advancing their clinical programs. All eyes within the psychiatric and neurological community remain on GHRS, as they surge forward in their mission to answer the desperate call for innovative depression treatments.

biopharmaceutical, clinical, depression