GH Research Announces Novel Therapies Symposium Presentation and Posters at the 2025 ECNP Congress

DUBLIN, Oct. 09, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced the acceptance of a Novel Therapies Symposium Presentation at the 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, the Netherlands from October 11 – 14, where Professor Wiesław J. Cubała, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, will present long-term clinical data on the safety and efficacy from the open label extension (OLE) of a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201).

Additionally, two posters have been accepted presenting safety and tolerability data from the open-label extension part of GH001-TRD-201 as well as data on the psychoactive effects of GH001 in patients with TRD from GH001-TRD-201.

“There remains a substantial unmet medical need for treatment-resistant depression, where many patients fail to achieve adequate relief with current therapies. In this context, the development of treatment options that combine strong efficacy, a favorable long-term safety profile, and a rapid-acting mechanism of action is particularly important,” said Professor Bernhard Baune, Director, Department of Psychiatry, University Hospital of Münster, Germany, and principal investigator in GH001-TRD-201. “Results from the 6-month open-label extension of GH001-TRD-201 provide important confirmation of GH001’s safety and tolerability profile. Treatment was well tolerated, with no treatment-related serious adverse events reported and no evidence of treatment-emergent suicidal intent or behavior. These findings reinforce confidence in GH001 as a novel and rapid-acting approach for TRD.”

GH Research is also organizing an Industry Satellite Symposium to discuss the potential of rapid-acting antidepressants in TRD.

Details:

Novel Therapies Symposium Presentation (ECNP) Presentation Title: Long-Term Data for GH001 in Patients with Treatment-Resistant Depression
Presenting Author: Wiesław J. Cubała, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
Date and Time: October 13 from 3:00pm to 4:20pm CET

Poster (ECNP) Poster Title: Psychoactive Effects of GH001 in Patients with Treatment-Resistant Depression: Results from a Phase 2b, Double-Blind, Randomized Controlled Trial
Presenting Author: Fabian Devlin, Mental Health Research for Innovation Centre, Mersey Care NHS Foundation Trust, United Kingdom
Date and Time: October 13 from 12:35pm to 2:00pm CET

Poster (ECNP) Poster Title: Safety and Tolerability Results from a Phase 2b, Double-Blind Trial with an Open-Label Extension of GH001 in Treatment-Resistant Depression
Presenting Author: Bernhard T. Baune, Department of Psychiatry, University of Münster, Münster, Germany
Date and Time: October 14 from 12:35pm to 2:00pm CET

Industry Satellite Symposium Title: Time Matters: The Potential of Rapid-Acting Antidepressants in Treatment-Resistant DepressionFaculty Members: (1) Prof Wiesław J. Cubała, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk; (2) Prof Michael E. Thase, MD, PhD, Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA, and Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia; (3) Prof Johannes G. Ramaekers, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk; (4) Dr Lisa Harding, MD, Mood Institute, Milton, CT, USA, and Department of Psychiatry, Yale School of Medicine
Date and Time: October 12 from 8:40am to 10:00am CET

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression (TRD).

About GH001

Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p