TEL AVIV, Israel and
RALEIGH, N.C., Jan. 28, 2021 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced a
manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN)
("Cosmo") to further expand manufacturing capacity for opaganib
(Yeliva®, ABC294640)[1], to address
prospective demand subsequent to potential global emergency use
authorizations.
"The growing concerns over viral mutations and the spread of new
potent and evasive viral strains have increased the dire need for
new COVID-19 therapeutics," said Reza
Fathi, PhD., RedHill's Senior VP, R&D. "We are very
pleased to expand the manufacturing capacity of opaganib with a
partner of Cosmo's quality. Opaganib is designed to act broadly
against different viral strains irrespective of mutations in the
Spike protein. Opaganib is a Phase 2/3-stage novel,
orally-administered sphingosine kinase-2 (SK2) inhibitor with
demonstrated antiviral, anti-inflammatory, and anti-thrombotic
activity. By targeting SK2, a human cell component involved in
viral replication irrespective of mutations in the viral Spike
protein, opaganib potentially addresses the emergence of new
strains."
"We are delighted to further strengthen our partnership with
RedHill on expanded opaganib manufacturing, and to play a part in
trying to help alleviate the suffering the coronavirus pandemic is
causing across the world, should opaganib be approved for use,"
said Davide Malavasi, Cosmo's
Head of Manufacturing.
The global Phase 2/3 study of opaganib in severe COVID-19
pneumonia (NCT04467840) is ongoing, with patients enrolled in more
than 30 sites in multiple countries. An interim independent Data
and Safety Monitoring Board (DSMB) futility analysis will be
conducted in the coming days, evaluating data from the first 135
subjects that have reached the primary endpoint. The study has
previously undergone two unblinded independent DSMB safety data
reviews, with unanimous recommendations to continue the study.
Preliminary data from a non-powered U.S. Phase 2 study of 40
hospitalized patients recently showed that opaganib was safe and
demonstrated greater improvement in reducing oxygen requirement by
end of treatment on Day 14 across key primary and secondary
efficacy outcomes, correlating with clinical improvement as defined
by the World Health Organization (WHO) ordinal scale.
About Opaganib (ABC294640, Yeliva®)
Opaganib, a new chemical entity, is a proprietary,
first-in-class, orally-administered, sphingosine kinase-2 (SK2)
selective inhibitor with demonstrated dual anti-inflammatory and
antiviral activity that targets a host cell component of viral
replication, potentially minimizing the likelihood of viral
resistance. Opaganib has also shown anticancer activity and has the
potential to target multiple oncology, viral, inflammatory, and
gastrointestinal indications.
Opaganib received Orphan Drug designation from the U.S. FDA for
the treatment of cholangiocarcinoma and is being evaluated in a
Phase 2a study in advanced cholangiocarcinoma and in a Phase 2
study in prostate cancer. Opaganib is also being evaluated as a
treatment for COVID-19 pneumonia in a global Phase 2/3 study and
has demonstrated positive safety and efficacy signals in
preliminary top-line data from a U.S. Phase 2 study.
Preclinical data have demonstrated anti-inflammatory, antiviral
and anti-thrombotic activities of opaganib, with the potential to
ameliorate inflammatory lung disorders, such as pneumonia, and
mitigate pulmonary fibrotic damage. Opaganib demonstrated potent
antiviral activity against SARS-CoV-2, the virus that causes
COVID-19, completely inhibiting viral replication in an in
vitro model of human lung bronchial tissue. Opaganib also
demonstrated reduced blood clot length, weight and total thrombus
score in a preclinical model of Acquired Respiratory Distress
Syndrome. Additionally, preclinical in vivo
studies[2] have demonstrated that opaganib
decreased fatality rates from influenza virus infection and
ameliorated Pseudomonas aeruginosa-induced lung injury by
reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage
fluids.
Opaganib was originally developed by U.S.-based Apogee
Biotechnology Corp. and completed multiple successful preclinical
studies in oncology, inflammation, GI, and radioprotection models,
as well as a Phase 1 clinical study in cancer patients with
advanced solid tumors and an additional Phase 1 study in multiple
myeloma.
The development of opaganib has been supported by grants and
contracts from U.S. federal and state government agencies awarded
to Apogee Biotechnology Corp., including from the NCI, BARDA, the
U.S. Department of Defense and the FDA Office of Orphan Products
Development.
The ongoing studies with opaganib are registered on
www.ClinicalTrials.gov, a web-based service by the U.S. National
Institute of Health, which provides public access to information on
publicly and privately supported clinical
studies.
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,
Movantik® for opioid-induced constipation in
adults[2], 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)
RHB-204, with an ongoing Phase 3 study for pulmonary
nontuberculous mycobacteria (NTM) disease; (ii) opaganib
(Yeliva®), a first-in-class SK2
selective inhibitor targeting multiple indications with a Phase 2/3
program for COVID-19 and Phase 2 studies for prostate cancer and
cholangiocarcinoma ongoing; (iii) RHB-107
(upamostat), a serine protease inhibitor with a planned
Phase 2/3 study in symptomatic COVID-19 and targeting multiple
other cancer and inflammatory gastrointestinal diseases; (iv)
RHB-104, with positive results from a first Phase 3 study
for Crohn's disease; (v) RHB-102
(Bekinda®), with positive results from a Phase 3
study for acute gastroenteritis and gastritis and positive results
from a Phase 2 study for IBS-D; and (vi) RHB-106, an
encapsulated bowel preparation. More information about the Company
is available at www.redhillbio.com /
https://twitter.com/RedHillBio.
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused on
developing and commercializing products to treat selected
gastrointestinal disorders and improve endoscopy quality measures
through aiding the detection of colonic lesions. Cosmo has also
developed medical devices for endoscopy and has recently entered
into a partnership with Medtronic for the global distribution of GI
Genius™ its artificial intelligence device for use in
coloscopies and GI procedures. Cosmo has licensed
Aemcolo® to RedHill Biopharma for the US and has
licensed Relafalk® to Dr. Falk Gmbh for the EU and other
countries. For additional information on Cosmo and its products
please visit the Company's website: www.cosmopharma.com
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, including
without limitation, the risk that the agreement with Cosmo will not
provide high-quality manufacturing capacity for opaganib or be
sufficient to meet market demands; the risk that opaganib will not
address resistance due to viral mutations; the risk of delay in
reporting top-line data from the global Phase 2/3 study of opaganib
in severe COVID-19 pneumonia and the timing of global emergency us
applications if at all; as well as other risks and uncertainties
associated with (i) the initiation, timing, progress and results of
the Company's research, manufacturing, preclinical 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 preclinical 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 risk that the Company will not succeed to
complete the patient recruitment of the global Phase 2/3 study; the
risk that the global Phase 2/3 clinical study evaluating opaganib
will not be successful or, if successful, will not suffice for
emergency use applications or regulatory marketing approval without
the need for additional clinical and/or other studies; (v) the
manufacturing, clinical development, commercialization, and market
acceptance of the Company's therapeutic candidates and Talicia®;
(vi) the Company's ability to successfully commercialize and
promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's
ability to establish and maintain corporate collaborations; (viii)
the Company's ability to acquire products approved for marketing in
the U.S. that achieve commercial success and build and sustain its
own marketing and commercialization capabilities; (ix) the
interpretation of the properties and characteristics of the
Company's therapeutic candidates and the results obtained with its
therapeutic candidates in research, preclinical studies or clinical
trials; (x) the implementation of the Company's business model,
strategic plans for its business and therapeutic candidates; (xi)
the scope of protection the Company is able to establish and
maintain for intellectual property rights covering its therapeutic
candidates and commercial products and its ability to operate its
business without infringing the intellectual property rights of
others; (xii) parties from whom the Company licenses its
intellectual property defaulting in their obligations to the
Company; (xiii) estimates of the Company's expenses, future
revenues, capital requirements and needs for additional financing;
(xiv) the effect of patients suffering adverse events using
investigative drugs under the Company's Expanded Access Program;
and (xv) 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 4, 2020. 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
|
Media contact
(U.S.):
Bryan
Gibbs
Vice
President
Finn
Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
|
[1] Opaganib is an investigational new drug, not available for
commercial distribution.
[2] Xia C. et al. Transient inhibition of sphingosine kinases
confers protection to influenza A virus infected mice. Antiviral
Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas
aeruginosa stimulates nuclear sphingosine-1-phosphate generation
and epigenetic regulation of lung inflammatory injury. Thorax. 2019
Jun;74(6):579-591.
[3] Full prescribing information for Movantik® (naloxegol) is
available at: www.Movantik.com .
[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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SOURCE RedHill Biopharma Ltd.