Full Press Release Details
GH Research Provides Business Updates and Highlights Key Upcoming
Dublin, Ireland, January 9, 2023 -
GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and
neurological disorders, today provided updates on its business and highlighted key upcoming milestones.
GH001 for the treatment of TRD
GH001 is our proprietary inhalable mebufotenin
(5-MeO-DMT) 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 (TRD) (GH001-TRD-201). We continue to expect
initiation of this trial in several European countries in the first quarter of 2023. Trial design details are described in our updated
corporate presentation, which is available in the investor section on our website.
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 (GH001-HV-106), 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.
GH002 is our mebufotenin (5-MeO-DMT) 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 (GH002-HV-105) has recently been initiated. We expect to complete
this trial in the fourth quarter of 2023.
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 (5-MeO-DMT) use in a therapeutic context, including
but not limited to the use of mebufotenin (5-MeO-DMT) for treatment of various disorders when administered by inhalation, or by nasal,
buccal, sublingual, intravenous, intramuscular or subcutaneous routes.
We are pleased to announce the selection of mebufotenin as the International
Nonproprietary Name (INN) for 5-MeO-DMT by the World Health Organization (WHO) Expert Advisory Panel on the International Pharmacopoeia
and Pharmaceutical Preparations. From this point forward, we will introduce the nomenclature mebufotenin into our communications.
About GH Research PLC
GH Research PLC is a clinical-stage biopharmaceutical
company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC's initial focus is on developing
its novel and proprietary mebufotenin (5-MeO-DMT) therapies for the treatment of patients with treatment-resistant depression (TRD).
GH Research PLC's annual report on Form 20-F filed
with the U.S. Securities and Exchange Commission for the year ended December 31, 2021 is available at www.ghres.com and shareholders may
receive a hard copy free of charge upon request.
Our lead product candidate, GH001, is formulated
for mebufotenin (5-MeO-DMT) administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer
clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity,
where 87.5% of patients with TRD were brought into an ultra-rapid remission with our GH001 single-day individualized dosing regimen in
the Phase 2 part of the trial, we believe that GH001 has potential to change the way TRD is treated today. Across the GH001 program, no
serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized
dosing regimen. GH001 is expected to enter Phase 2b clinical development in TRD in the first quarter of 2023.
GH002 is our mebufotenin
(5-MeO-DMT) product candidate formulated for administration via a proprietary injectable approach. GH002 is currently in Phase 1 clinical
development. GH003 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intranasal administration
approach. GH003 is currently in preclinical development.
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 future results of operations and financial position, our cash runway, business
strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory
submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of
management for future operations, are forward-looking statements. 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 document speak only as of the date of this press release. 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.