RHB-107 (upamostat) accepted for inclusion in ACESO's PROTECT
adaptive platform trial for early COVID-19 outpatient treatment to
be conducted in the U.S., Thailand, Ivory
Coast and South Africa
The substantial 300-patient Phase 2 study, predominantly
funded by the U.S. Government Department of Defense's Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense (JPEO-CBRND), has received FDA clearance to start (expected
Q3/23) and is estimated to be completed by end of 2024
If approved, RHB-107, a novel, oral, once-daily,
broad-acting, host-directed antiviral is expected to act
independently of viral spike protein
mutations1, would potentially
target a multi-billion-dollar early COVID-19 treatment
market
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
TEL AVIV, Israel and RALEIGH,
NC, July 31, 2023 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced that RHB-107
(upamostat)3 has been accepted for inclusion in the
Austere environments Consortium for Enhanced Sepsis Outcomes'
(ACESO) U.S. Government-supported PROTECT multinational platform
trial for early COVID-19 outpatient treatment to be conducted in
the U.S., Thailand, Ivory Coast and South Africa. The Company also announced that
the Phase 2 study, predominantly funded by the U.S. Government
Department of Defense's Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND), has received FDA clearance to start and is estimated
to be completed by end of 2024.
Expected to begin enrolling patients in Q3 2023, 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 investigational products for inclusion in the study
was based on review of the preclinical and early clinical data,
evaluating, safety, tolerability, and efficacy of the IP. Selection
is also based on route of administration and product availability.
Products with oral, subcutaneous, and intramuscular delivery modes
have been prioritized due to acceptability and feasibility of
administration.
"Having RHB-107 accepted for inclusion in the PROTECT platform
study, following an extensive review of the potential value it can
bring, by both the scientific and governmental bodies involved in
the study offers us a chance to further verify the promising
efficacy results, including 100% reduction in hospitalization due
to COVID-19, that we delivered in 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, broad-acting, host-directed antiviral that is expected to
act independently of viral spike protein mutations and, if
approved, would add to treatment options such as Paxlovid (a
multi-billion-dollar product), in the early COVID-19 treatment
paradigm. RHB-107's development runs alongside RedHill's other U.S.
Government-funded program with opaganib, a novel oral drug being
developed in collaboration with the National Institutes of Health
Radiation and Nuclear Countermeasures Program for Acute Radiation
Syndrome."
Data from RHB-107's 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 approx. 88% reduction in reported new severe COVID-19
symptoms after treatment initiation, with only 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 from severe COVID-19 symptoms with a median of 3 days to
recovery with upamostat compared to 8 days with placebo.
Discussions for external non-dilutive funding for RHB-107 Phase
3 COVID-19 development, in addition to the platform study, are
advancing. Several collaborative projects for pandemic preparedness
testing RHB-107, with government and non-government bodies, in a
range of preclinical studies against other viral targets are
ongoing and under discussion with government and non-government
bodies.
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.
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.
RedHill acquired the exclusive worldwide rights to RHB-107,
excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (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 the JPEO-CBRND
The Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint
Force by providing medical countermeasures and defense equipment
against chemical, biological, radiological and nuclear (CBRN)
threats. JPEO-CBRND's goal is to enable the Joint Force to fight
and win unencumbered by a CBRN environment. JPEO-CBRND facilitates
the rapid response, advanced development, manufacturing and
acquisition of medical solutions, such as vaccines, therapeutics,
and diagnostics, to combat CBRN and emerging threats such as
COVID-19. To learn more about JPEO-CBRND's COVID-19 response, visit
https://www.jpeocbrnd.osd.mil/coronavirus exit disclaimer icon or
follow JPEO-CBRND on social media at @JPEOCBRND.
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 adults4,
and Aemcolo® for the treatment of travelers'
diarrhea in adults5. 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, 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 / https://twitter.com/RedHillBio.
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 growth in prescriptions will
not continue and the addition of new generating products will not
occur, that we will not be successful in obtaining non-dilutive
development funding for RHB-107, that we will not be successful in
increasing sales of our commercial products, including due to
market conditions, that the Phase 2/3 COVID-19 study for RHB-107
may not be successful and, even if successful, such studies and
results may not be sufficient for regulatory applications,
including emergency use or marketing applications, and that
additional COVID-19 studies for opaganib and RHB-107 are likely to
be required, as well as risks and uncertainties associated with the
risk that the Company will not successfully commercialize its
products; 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;
(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; and (xiv) competition from other companies
and technologies within the Company's industry. 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 March 17, 2022. 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.
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. This project was supported by the Joint
Program Executive Office for Chemical, Biological, Radiological and
Nuclear Defense (JPEO-CBRND). 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] Preliminary data from a recent
in vitro study
[2] https://www.ijidonline.com/article/S1201-9712(22)00638-5/fulltext
[3] RHB-107 (upamostat) is an investigational new drug,
not available for commercial distribution in the United States.
[4] Full prescribing information for
Talicia® (omeprazole magnesium, amoxicillin and
rifabutin) is available at: www.Talicia.com.
[5] Full prescribing information for
Aemcolo® (rifamycin) is available at:
www.Aemcolo.com.
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