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

Rhea-AI Summary

GH Research (Nasdaq: GHRS) announced accepted presentations and posters at the 38th ECNP Congress in Amsterdam, Oct 11–14, 2025. A Novel Therapies Symposium presentation on Oct 13, 3:00–4:20pm CET will report long‑term safety and efficacy data from the open‑label extension of the Phase 2b GH001-TRD-201 trial in treatment‑resistant depression (TRD). Two posters report psychoactive effects and OLE safety/tolerability; an Industry Satellite Symposium on rapid‑acting antidepressants is set for Oct 12, 8:40–10:00am CET.

Insights

Clinical Development Analyst

6-month open‑label safety data for GH001 presented at ECNP supports tolerability but does not change efficacy proof.

GH Research will present long-term safety and psychoactive-effect data from the Phase 2b trial and its 6-month open‑label extension at ECNP on October 13 and October 14.

The disclosed facts note no treatment‑related serious adverse events and no treatment‑emergent suicidal intent or behavior in the open‑label extension, which directly addresses a key safety concern for rapid‑acting antidepressants. These specific safety observations strengthen the tolerability narrative but do not by themselves confirm sustained efficacy in a controlled setting.

Watch for the detailed OLE datasets and any prespecified efficacy measures presented on October 13, plus poster-level breakdowns of psychoactive effects and tolerability on October 13–October 14. Near-term value will depend on the magnitude and durability of effect sizes reported and whether controlled endpoints align with the open‑label findings over the next few months.

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 38^th 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 Depression
Faculty 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<0.0001), we believe that GH001 has potential to change the way TRD is treated today.

Forward-Looking Statements

This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our plans, strategies and prospects for our business, including the development and therapeutic potential of mebufotenin. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations
Julie Ryan
GH Research PLC
investors@ghres.com

FAQ

What will GH Research (GHRS) present at ECNP 2025 on Oct 13?

GHRS will present long‑term safety and efficacy data from the open‑label extension of the Phase 2b GH001‑TRD‑201 trial on Oct 13, 3:00–4:20pm CET.

When and where is the GH001 psychoactive effects poster presentation for GHRS (GHRS)?

The psychoactive effects poster will be presented on Oct 13 from 12:35pm to 2:00pm CET at ECNP 2025.

What safety data will GHRS (GHRS) present from the GH001‑TRD‑201 trial?

A poster on Oct 14, 12:35pm–2:00pm CET will present safety and tolerability results from the Phase 2b trial and its open‑label extension.

Who is presenting the long‑term GH001 data for GHRS (GHRS) at ECNP 2025?

Professor Wiesław J. Cubała from the Medical University of Gdańsk is the presenting author for the long‑term GH001 data presentation.

When is the GH Research Industry Satellite Symposium on rapid‑acting antidepressants?

The Industry Satellite Symposium titled 'Time Matters' is scheduled for Oct 12 from 8:40am to 10:00am CET.

Which GH001‑TRD‑201 trial findings are highlighted in GHRS presentations at ECNP?

Presentations highlight long‑term safety, tolerability, and psychoactive‑effect data from the open‑label extension of the Phase 2b GH001‑TRD‑201 trial.