First patient enrolled in the global, 300-patient, Phase 2
adaptive platform trial arm of RHB-107
(upamostat)1 for early COVID-19 outpatient
treatment, funded through non-dilutive external sources, including
the U.S. Department of Defense
The study is expected to be completed by the end of
2024
RHB-107 successfully met the primary endpoint of safety and
tolerability and delivered promising efficacy results, including
marked reduction in hospitalization due to COVID-19 in a U.S. Phase
2 study2
RHB-107 is a novel, oral, once-daily, host-directed potential
broad-acting antiviral expected to act independently of viral spike
protein mutations3
RALEIGH,
N.C. and TEL-AVIV,
Israel, April 24, 2024 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced that the first
patient has been enrolled in the Austere environments Consortium
for Enhanced Sepsis Outcomes' (ACESO) U.S. government-supported
PROTECT multinational platform trial for early COVID-19 outpatient
treatment. RHB-107 (upamostat) is the first drug being tested in
this platform study. Funded through non-dilutive external sources,
including the U.S. Department of Defense, the PROTECT study is
expected to be conducted in the U.S., Thailand, Ivory
Coast, South Africa and
Uganda, and is estimated to be
completed by the end of 2024.
"Enrollment of the first patient in the study marks an important
milestone for RHB-107 in the 300-patient U.S. government-supported
PROTECT platform study, which could add significant validating data
to the previous marked reduction in hospitalizations due to
COVID-19 seen in the RHB-107 arm of our earlier U.S. Phase 2
study," said Gilead Raday,
RedHill's Chief Operating Officer and Head of R&D. "RHB-107
is a novel, potentially broad-acting, host-directed antiviral that
is expected to act independently of viral spike protein mutations.
If approved, RHB-107 could provide a much-needed additional option
for use in the early COVID-19 treatment space, alongside Paxlovid.
Additionally, with both RHB-107 and opaganib recently demonstrating
distinct synergistic effect when combined individually with
remdesivir in an in vitro Ebola study, we are making
encouraging progress with our pipeline assets for pandemic
preparedness."
Data from RHB-107's previous U.S. Phase 2 study showed a 100%
reduction in hospitalization due to COVID-19, with zero patients
(0/41) on the RHB-107 arms versus 15% (3/20) hospitalized for
COVID-19 on the placebo-controlled arm (nominal p-value=0.0317).
The study also showed an approximately 88% reduction in reported
new severe COVID-19 symptoms after treatment initiation, with 2.4%
of the RHB-107 treated group (1/41) versus 20% (4/20) of patients
in the placebo-controlled arm (nominal p-value=0.036) reporting new
severe COVID-19 symptoms. Further post-hoc analysis showed
faster recovery periods from severe COVID-19 symptoms with a median
of 3 days to recovery with upamostat compared to 8 days with the
placebo.
The ACESO PROTECT study is an adaptive, randomized, double
blind, multi-site Phase 2 platform trial, being conducted by
researchers from ACESO and partner organizations, and administered
by the Henry M. Jackson Foundation for the Advancement of Military
Medicine (HJF). The study will compare investigational products
(IPs) to control, in standard-risk, non-hospitalized adult
SARS-CoV-2 infected participants with at least two moderate-severe
symptoms at baseline. RHB-107 is the initial drug being evaluated
in the early treatment arm of the study. The primary efficacy
assessment in the early treatment indication will be time to
sustained alleviation or resolution of COVID-19 symptoms.
Participants will be followed for a period of up to 12 weeks.
Selection of IPs for inclusion in the ACESO PROTECT study is
based on review of the preclinical and early clinical data,
evaluating safety, tolerability, and efficacy. Selection is also
based on route of administration and product availability.
RHB-107's development for COVID-19 runs parallel to the
development of opaganib, RedHill's other novel oral drug, for Acute
Radiation Syndrome, being done in collaboration with, and funded
by, the U.S. government's National Institutes of Health Radiation
and Nuclear Countermeasures Program. Both RHB-107 and opaganib also
recently demonstrated distinct synergistic effect when combined
individually with remdesivir, significantly improving potency while
maintaining cell viability, in a U.S. Army-funded and conducted
in vitro Ebola virus study.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, once-daily orally
administered investigational antiviral, that targets human serine
proteases involved in preparing the spike protein for viral entry
into target cells. Because it is host-cell targeted, RHB-107 is
expected to also be effective against emerging viral variants with
mutations in the spike protein. RHB-107 is well tolerated; in the
initial COVID-19 study, among 41 patients only one reported a
drug-related adverse reaction (a mild, self-limited, rash).
In addition, RHB-107 inhibits several proteases targeting cancer
and inflammatory gastrointestinal disease. RHB-107 has undergone
several Phase 1 studies and two Phase 2 studies, demonstrating its
clinical safety profile in approximately 200 patients[4].
RedHill acquired the exclusive worldwide rights to RHB-107,
excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharma AG (FSE: HPHA)
(formerly WILEX AG) for all indications.
About HJF
The Henry M. Jackson Foundation for the Advancement of Military
Medicine, Inc. (HJF), now celebrating its 40th
anniversary, is a global nonprofit organization with the mission to
advance military medicine. HJF's scientific, administrative and
program operations services empower investigators, clinicians, and
medical researchers around the world to make discoveries in all
areas of medicine. HJF serves as a trusted and responsive link
between the military medical community, federal and private
partners, and the millions of warfighters, veterans, and civilians
who benefit from military medicine. For more information, visit
www.hjf.org.
About ACESO
The Austere environments Consortium for Enhanced Sepsis Outcomes
(ACESO) aims to improve survival for patients with sepsis in
resource-limited settings through development of host-based
technology solutions and evidence-based clinical management
strategies. Founded in 2010, ACESO brings together a consortium
comprised of academic, non-profit, governmental, and industry
partners that is administered by HJF. ACESO has established a
global clinical research network to develop and deliver
cutting-edge tools and strategies to save lives in austere
settings.
For more information, visit
www.aceso-sepsis.org.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty
biopharmaceutical company primarily focused on gastrointestinal and
infectious diseases. RedHill promotes the gastrointestinal drugs
Talicia®, for the treatment of Helicobacter
pylori (H. pylori) infection in
adults[5], and Aemcolo®,
for the treatment of travelers' diarrhea in
adults[6]. RedHill's key clinical late-stage
development programs include: (i) opaganib (ABC294640),
a first-in-class oral broad-acting, host-directed
SPHK2 selective inhibitor with potential for pandemic preparedness,
targeting multiple indications with a U.S. government collaboration
for development for Acute Radiation Syndrome (ARS), a Phase 2/3
program for hospitalized COVID-19, and a Phase 2 program in
oncology; (ii) RHB-107 (upamostat), an oral
broad-acting, host-directed, serine protease inhibitor with
potential for pandemic preparedness is in late-stage development as
a treatment for non-hospitalized symptomatic COVID-19, with
non-dilutive external funding covering the entirety of the RHB-107
arm of the 300-patient Phase 2 adaptive platform trial, and is also
targeting multiple other cancer and inflammatory gastrointestinal
diseases; (iii) RHB-102, with potential UK submission
for chemotherapy and radiotherapy induced nausea and vomiting,
positive results from a Phase 3 study for acute gastroenteritis and
gastritis and positive results from a Phase 2 study for IBS-D;
(iv) RHB-104, with positive results from a first Phase
3 study for Crohn's disease; and (v) RHB-204, a
Phase 3-stage program for pulmonary nontuberculous mycobacteria
(NTM) disease.
More information about the Company is available at:
www.redhillbio.com / twitter.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements may be preceded by the words "intends,"
"may," "will," "plans," "expects," "anticipates," "projects,"
"predicts," "estimates," "aims," "believes," "hopes," "potential"
or similar words. Forward-looking statements are based on certain
assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company's control and
cannot be predicted or quantified, and consequently, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include,
without limitation, the risk that the ACESO PROTECT study for
RHB-107 may not be completed or, if completed, may not be
successful or, even if successful, may not be sufficient support
for regulatory applications, including emergency use or marketing
applications, that additional COVID-19 studies for RHB-107 are
likely to be required, and that we will not be successful in
obtaining further non-dilutive development funding for RHB-107.
Such risks and uncertainties also include those associated with the
risk that the Company will not successfully commercialize its
products, that the growth in prescriptions will not continue and
the addition of new generating products will not occur, and that we
will not be successful in increasing sales of our commercial
products, including due to market and other conditions; as well as
risks and uncertainties associated with (i) the initiation, timing,
progress and results of the Company's research, manufacturing,
pre-clinical studies, clinical trials, and other therapeutic
candidate development efforts, and the timing of the commercial
launch of its commercial products and ones it may acquire or
develop in the future; (ii) the Company's ability to advance its
therapeutic candidates into clinical trials or to successfully
complete its pre-clinical studies or clinical trials the
development of a commercial companion diagnostic for the detection
of MAP; (iii) the extent and number and type of additional studies
that the Company may be required to conduct and the Company's
receipt of regulatory approvals for its therapeutic candidates, and
the timing of other regulatory filings, approvals and feedback;
(iv) the manufacturing, clinical development, commercialization,
and market acceptance of the Company's therapeutic candidates and
Talicia®; (v) the Company's ability to successfully commercialize
and promote Talicia® and Aemcolo®; (vi) the Company's ability to
establish and maintain corporate collaborations; (vii) the
Company's ability to acquire products approved for marketing in the
U.S. that achieve commercial success and build its own marketing
and commercialization capabilities; (viii) the interpretation of
the properties and characteristics of the Company's therapeutic
candidates and the results obtained with its therapeutic candidates
in research, pre-clinical studies or clinical trials; (ix) the
implementation of the Company's business model, strategic plans for
its business and therapeutic candidates; (x) the scope of
protection the Company is able to establish and maintain for
intellectual property rights covering its therapeutic candidates
and its ability to operate its business without infringing the
intellectual property rights of others; (xi) parties from whom the
Company licenses its intellectual property defaulting in their
obligations to the Company; (xii) estimates of the Company's
expenses, future revenues, capital requirements and needs for
additional financing; (xiii) the effect of patients suffering
adverse experiences using investigative drugs under the Company's
Expanded Access Program; (xiv) competition from other companies and
technologies within the Company's industry, and (xv) the hiring and
employment commencement date of executive managers. More detailed
information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the
Company's filings with the Securities and Exchange Commission
(SEC), including the Company's Annual Report on Form 20-F filed
with the SEC on April 28, 2023. All
forward-looking statements included in this press release are made
only as of the date of this press release. The Company assumes no
obligation to update any written or oral forward-looking statement,
whether as a result of new information, future events or otherwise
unless required by law.
This project was supported by the Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND) Joint Project Lead for Enabling Biotechnologies (JPL
CBRND EB) in collaboration with the Defense Health Agency
(DHA) COVID funding initiative for The Henry M. Jackson Foundation
for the Advancement of Military Medicine, Inc., Contract
W911QY-20-9-0004 for this
effort.
The views expressed in this press release reflect the results
of research conducted by the author and do not necessarily reflect
the official policy or position of the Henry M. Jackson Foundation
for the Advancement of Military Medicine, Inc., the Department of
the Navy, Department of the Army, Department of Defense, nor the
United States Government. References to non-federal entities or
their products do not constitute or imply Department of Defense or
Army endorsement of any company, organization, or product. To the
Company's knowledge, the study protocol is in compliance with all
applicable federal regulations governing the protection of human
subjects.
Company
contact:
Adi Frish
Chief Corporate &
Business Development Officer
RedHill
Biopharma
+972-54-6543-112
adi@redhillbio.com
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Category: R&D
[1] RHB-107 (upamostat) is an investigational new
drug, not available for commercial distribution in the United States.
[2]
https://www.ijidonline.com/article/S1201-9712(22)00638-5/fulltext
[3] Preliminary data from a recent in vitro
study
[4]
https://www.ijidonline.com/article/S1201-9712(22)00638-5/fulltext
[5] Talicia® (omeprazole magnesium,
amoxicillin and rifabutin) is indicated for the treatment of H.
pylori infection in adults. For full prescribing information
see: www.Talicia.com.
[6] Aemcolo® (rifamycin) is indicated
for the treatment of travelers' diarrhea caused by noninvasive
strains of Escherichia coli in adults. For full prescribing
information see: www.aemcolo.com.
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SOURCE RedHill Biopharma Ltd.