The U.S. government's Chemical Medical Countermeasures (Chem
MCM) Program and Chemical Countermeasures Research Program (CCRP),
managed respectively by ASPR/BARDA and NIH/NIAID, in collaboration
with Battelle[1], have selected opaganib for evaluation
as a potential medical countermeasure (MCM) against Sulfur Mustard
exposure
Opaganib, a novel oral small molecule, is the first
sphingosine kinase-2 (SPHK2) inhibitor investigational drug
targeting sphingolipid metabolism to be evaluated as a chemical
countermeasure
Selection for the therapeutic testing/screening program,
following opaganib's previous acceptance into the Radiation and
Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome
(ARS), provides the potential to see broad activity across both
radiation and Sulfur Mustard injuries
Opaganib has five-year shelf-life and is easy to administer
and distribute for use against potential chemical weapon attack, if
approved by the U.S. Food and Drug Administration (FDA)
Opaganib is being developed for multiple additional
indications, including COVID-19, acute respiratory distress
syndrome (ARDS) and oncology
TEL
AVIV, Israel and RALEIGH,
N.C., March 5, 2024 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, together with its partner
Apogee Biotechnology Corporation, today announced that
opaganib[2] has been selected by the U.S. government's
Chemical Medical Countermeasures (Chem MCM) Program and Chemical
Countermeasures Research Program (CCRP) for evaluation as a
potential medical countermeasure (MCM) against inhalation Sulfur
Mustard exposure. The overall evaluation will also include
assessment of opaganib's efficacy against sub-chronic fibrosis and
acute respiratory distress syndrome (ARDS) resulting from Sulfur
Mustard exposure.
The Chem MCM Program is administered by the Biomedical Advanced
Research and Development Authority (BARDA), a component of the
Administration for Strategic Preparedness and Response (ASPR)
within the U.S. Department of Health and Human Services (HHS), and
the CCRP is managed by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the HHS National Institutes of
Health (NIH).
Sulfur Mustard is a powerful alkylating chemical warfare agent.
Exposure to Sulfur Mustard causes extensive skin blistering and
severe injury to the eyes, lungs, and multiple organs, causing
potentially fatal damage. Primarily affecting the lungs, Sulfur
Mustard poisoning can result in symptoms such as acute lung injury,
acute respiratory distress syndrome, bronchiolitis obliterans,
fibrosis, and subsequent associated infections.
"With the alarming increase in global geo-political instability,
the opportunity to evaluate opaganib as a potential vital
protective agent against chemical attack is inspiring. We, and our
development partner, Apogee Biotechnology Corporation, are
delighted to partner with the NIH/NIAID, ASPR/BARDA, and Battelle
in our efforts to make a significant difference in this area of
huge medical and societal need," said Dror Ben-Asher, RedHill's Chief Executive
Officer. "Opaganib is the first selective sphingosine kinase-2
(SPHK2) inhibitor investigational drug targeting sphingolipid
metabolism to be evaluated as a chemical countermeasure. Its
selection for the U.S. government's Chemical Countermeasures
Research Program, following opaganib's previous acceptance into the
U.S government's Radiation and Nuclear Countermeasures Program for
Acute Radiation Syndrome (ARS), provides the potential to see broad
activity across both radiation and Sulfur Mustard injuries."
Opaganib, a novel oral, small molecule pill with a five-year
shelf-life, is easy to administer and distribute for use against
potential chemical weapon attack, if approved by the FDA.
About Opaganib (ABC294640)
Opaganib, a
proprietary investigational host-directed and potentially
broad-acting drug, is a first-in-class, orally administered
sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer,
anti-inflammatory and antiviral activity, targeting multiple
potential diseases, including gastrointestinal acute radiation
syndrome (GI-ARS), COVID-19, other viruses as part of pandemic
preparedness, and cholangiocarcinoma (bile duct cancer).
Opaganib's host-directed action is thought to work through the
inhibition of multiple pathways, the induction of autophagy and
apoptosis, and disruption of viral replication, through
simultaneous inhibition of three sphingolipid-metabolizing enzymes
in human cells (SPHK2, DES1 and GCS).
Opaganib was selected by the U.S. government's Radiation and
Nuclear Countermeasures Program (RNCP), led by the National
Institute of Allergy and Infectious Diseases, part of the HHS
National Institutes of Health, for the nuclear medical
countermeasures product development pipeline as a potential
treatment for Acute Radiation Syndrome (ARS).
Opaganib has demonstrated antiviral activity against SARS-CoV-2,
multiple variants, and several other viruses, such as Influenza A.
Opaganib also recently demonstrated a distinct synergistic effect
when combined individually with remdesivir (Veklury®, Gilead
Sciences Inc., Nasdaq: GILD), significantly improving potency while
maintaining cell viability, in a U.S. Army-funded and conducted
in vitro Ebola virus study.
Being host-targeted, and based on data accumulated to date,
opaganib is expected to maintain effect against emerging viral
variants. In prespecified analyses of Phase 2/3 clinical data in
hospitalized patients with moderate to severe COVID-19, oral
opaganib demonstrated improved viral RNA clearance, faster time to
recovery and significant mortality reduction in key patient
subpopulations versus placebo on top of standard of care. Opaganib
has demonstrated its safety and tolerability profile in more than
470 people in multiple clinical studies and expanded access use.
Data from the opaganib global Phase 2/3 study was published
in medRxiv.
Opaganib has received Orphan Drug designation from the FDA for
the treatment of cholangiocarcinoma and has undergone studies in
advanced cholangiocarcinoma (Phase 2a) and prostate cancer.
Opaganib also has a Phase 1 chemoradiotherapy study protocol ready
for FDA-IND submission.
Opaganib has also shown positive preclinical results in renal
fibrosis, and has the potential to target multiple oncology,
radioprotection, viral, inflammatory, and gastrointestinal
indications.
About Battelle
Every day, the people of Battelle apply
science and technology to solving what matters most. At major
technology centers and national laboratories around the world,
Battelle conducts research and development, designs and
manufactures products, and delivers critical services for
government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929,
Battelle serves the national security, health and life sciences,
and energy and environmental industries. For more information,
visit www.battelle.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[3], and Aemcolo®,
for the treatment of travelers' diarrhea in
adults[4]. 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.
RedHill is open to opportunities to acquire revenue generating
assets in various indications, aligned to our strategic direction.
Trading in RedHill's shares, ADSs and Warrants is regulated by the
Securities and Exchange Commission (SEC), and the Company is
committed to work in compliance with all relevant SEC and FDA
regulations and requirements.
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 and may discuss investment opportunities, stock analysis,
financial performance, investor relations, and market trends. Such
statements, including, but not limited to, statements regarding the
intended use of net proceeds from the offering, may be preceded by
the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims,"
"believes," "hopes," "potential" or similar words and include
statements regarding the risk that the Company will not comply with
the listing requirements of the Nasdaq Capital Market ("Nasdaq") to
remain listed for trading on Nasdaq, the addition of new revenue
generating products, out-licensing of the Company's development
pipeline assets, timing of opaganib's development for Acute
Radiation Syndrome, non-dilutive development funding from RHB-107
and its inclusion in a key platform study. 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, market
and other conditions, the risk that opaganib's evaluation for
Sulfur Mustard exposure may not be completed or, if completed, may
not be successful; the addition of new revenue generating products
or out-licensing transactions will not occur; the risk that
acceptance onto the RNCP Product Development Pipeline will not
guarantee ongoing development or that any such development will not
be completed or successful; the risk that the FDA does not agree
with the Company's proposed development plans for opaganib for any
indication, the risk that observations from preclinical studies are
not indicative or predictive of results in clinical trials; the
risk that the FDA pre-study requirements will not be met and/or
that the Phase 3 study of RHB-107 in COVID-19 outpatients will not
be approved to commence or if approved, will not be completed or,
should that be the case, that we will not be successful in
obtaining alternative non-dilutive development funding for RHB-107,
the risk that HB-107's late-stage development for non-hospitalized
COVID-19 will not benefit from the resources redirected from the
terminated RHB-204 Phase 3 study, 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 or 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.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
[1] Battelle is a leading, independent,
nonprofit organization that partners with government, and others,
to deliver critical scientific services.
[2] Opaganib is an investigational new drug, not
available for commercial distribution.
[3] 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.
[4] 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.
Logo -
https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/redhills-opaganib-selected-for-evaluation-by-barda-and-nih-countermeasures-programs-302079686.html
SOURCE RedHill Biopharma Ltd.