GH Research Provides Updates and Guidance on its Clinical Development Program for GH001 in Treatment-Resistant Depression
29 Septembre 2023 - 10:45PM
GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical
company dedicated to transforming the treatment of psychiatric and
neurological disorders, today provided updates and guidance on its
clinical development program for GH001, its proprietary inhalable
mebufotenin (5-MeO-DMT) product candidate, in treatment-resistant
depression (TRD).
Development Strategy
As previously announced, following successful
completion of our Phase 1/2 trial of GH001 in patients with TRD
(GH001-TRD-102), we are recruiting for a European multi-center,
randomized, double-blind, placebo-controlled Phase 2b trial of
GH001 in patients with TRD (GH001-TRD-201), where GH001 is
administered using an externally-sourced inhalation device.
Separately, we submitted, in the third quarter of 2023, an
Investigational New Drug Application (IND) for GH001 with the U.S.
Food and Drug Administration (FDA), with the purpose to initiate a
Phase 1 healthy volunteer clinical pharmacology trial, where GH001
is administered using our proprietary aerosol delivery device
(GH001-HV-106). The trial, subject to regulatory clearance from the
FDA, is designed to support bridging to the clinical data generated
with the externally-sourced inhalation device we currently use in
our European Phase 2b trial such that we can initiate, subject to
data and regulatory clearance, a subsequent global Phase 3 pivotal
program using our proprietary device.
Update and Guidance on European Phase 2b
Clinical Trial of GH001 in Patients with TRD
Our multi-center, randomized, double-blind,
placebo-controlled Phase 2b trial of GH001 in patients with TRD
(GH001-TRD-201) is now approved in seven European countries and is
expected to recruit approximately 80 patients across approximately
20 sites. The primary objective of the trial is to determine the
efficacy of our single-day individualized dosing regimen (IDR) of
GH001 compared with placebo in improving depressive symptoms as
assessed by the mean change from baseline in Montgomery-Åsberg
Depression Rating Scale (MADRS) at the end of the 7-day
double-blind phase. The double-blind phase is followed by a 6-month
open-label extension phase where all patients can receive treatment
with the GH001 IDR as-needed, based on the patient’s clinical
status. With 14 sites initiated and additional site initiations
scheduled, we are now in a position to provide guidance on
completion of the double-blind phase of this trial, which is
expected to occur in the third quarter of 2024, with top-line data
available in the third or the fourth quarter of 2024.
Update on IND for GH001
We recently submitted an IND for GH001 with the
FDA. At the end of the 30-day review period, the FDA advised that
it had placed our IND on clinical hold due to “21 CFR
312.42(b)(1)(iv): Insufficient information to assess risks to human
subjects”. The FDA indicated that a letter with additional details
will be issued within 30 days. We are awaiting that follow-up
letter from the FDA and look forward to working with them to
resolve any outstanding concerns. We plan to provide an update
in our next earnings release in November 2023.
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/A
filed with the U.S. Securities and Exchange Commission for the year
ended December 31, 2022 is available at www.ghres.com and
shareholders may receive a hard copy free of charge upon
request.
About GH001
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 TRD. Based on the observed clinical activity, where
87.5% of patients with TRD were brought into an ultra-rapid
remission with our GH001 individualized single-day dosing regimen
in the Phase 2 part of the trial, we believe that GH001 has
potential to change the way TRD is treated today. GH001 is
currently in a multi-center, randomized, double-blind,
placebo-controlled Phase 2b trial in patients with TRD and in two
Phase 2a proof-of-concept trials in patients with bipolar II
disorder and a current depressive episode and in patients with
postpartum depression.
About GH002 and GH003
GH002 is our mebufotenin (5-MeO-DMT) product
candidate formulated for administration via a proprietary
intravenous 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. We anticipate developing GH002 and GH003 in
subpopulations and confined use scenarios within our focus
area of psychiatric and neurological disorders.
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, business strategy, product
candidates, medical devices required to deliver these product
candidates, research pipeline, ongoing and currently planned
preclinical studies and clinical trials, regulatory submissions and
approvals, including the FDA’s communication plans related to the
clinical hold on the GH001 IND, our plans and expectations for
discussions with the FDA and the outcomes of such discussions,
research and development costs, cash runway, 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 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 RyanGH Research
PLCinvestors@ghres.com
GH Research (NASDAQ:GHRS)
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