The new non-dilutive external funding, additional to the
previously announced U.S. Government non-dilutive funding, now
covers the entirety of the RHB-107
(upamostat)[1] arm of the
ACESO PROTECT adaptive platform trial for early COVID-19 outpatient
treatment
This additional funding amounts to approximately
$4.8M directed towards evaluation of
RHB-107 in the PROTECT study
In addition to the platform's Master Protocol, the
300-patient Phase 2 RHB-107 arm has received FDA clearance to
start, with the first patient expected to be enrolled in the coming
weeks. The study is being conducted in the U.S., Thailand, Ivory
Coast, South Africa and
Uganda, and is estimated to be
completed by 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 study[2]
If approved, RHB-107, a novel, oral, once-daily,
host-directed potential broad-acting antiviral expected to act
independently of viral spike protein
mutations[3], would
target the multi-billion-dollar early COVID-19 treatment
market
RALEIGH,
N.C. and TEL-AVIV,
Israel, Dec. 4, 2023 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced new
non-dilutive external funding, additional to the previously
announced U.S. Government funding, which now covers the entirety of
the RHB-107 (upamostat) arm of the ACESO PROTECT adaptive platform
trial for early COVID-19 outpatient treatment. This additional
funding amounts to approximately $4.8M directed towards evaluation of RHB-107 in
the PROTECT study.
The 300-patient Phase 2 RHB-107 arm of the PROTECT study has
received FDA clearance to start, with the first patient expected to
be enrolled in the coming weeks. The study is being conducted in
the U.S., Thailand, Ivory Coast, South
Africa and Uganda, and is
estimated to be completed by end of 2024.
"The new non-dilutive external funding, covering the entirety of
the RHB-107 arm of the ACESO PROTECT study, is, we believe,
indicative of the ongoing and pressing medical need for new oral,
small molecule, treatment options for early COVID-19 and
demonstrates the need to test the ability of new potential
therapeutics, such as RHB-107, to provide such an option. We
believe that the PROTECT study 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, once daily, orally-administered, potentially
broad-acting, host-directed small molecule drug that is expected to
act independently of viral spike protein mutations. If approved,
RHB-107 could provide a much-needed additional option to Paxlovid
in the billion-dollar early COVID-19 treatment space."
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
is the first drug to be studied in the ACESO PROTECT study.
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.
About RHB-107 (upamostat)
RHB-107 is a proprietary,
first-in-class, once-daily orally administered investigational
drug, 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 a
clinically safe profile in approximately 200 patients to date2.
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 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[4], and Aemcolo®,
for the treatment of travelers' diarrhea in
adults[5]. 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 / 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.
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. 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] 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.
[5] 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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