TEL AVIV, Israel and
RALEIGH, NC, Feb. 23, 2021 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced its plans to
expand the Company's global Phase 2/3 study of
opaganib[1] in patients with severe COVID-19 to the
U.S., following U.S. Food and Drug Administration (FDA) review of
the data from the U.S. Phase 2 study of opaganib and receipt of its
recommendations.
Expansion of the global Phase 2/3 study to the U.S. will entail
adjustments to the protocol based on the FDA's recommendations and
ongoing discussions. The expansion of the study to the U.S. will
help further speed-up enrollment, expanding the study to a total of
8 countries and approximately 40 recruiting sites, with additional
sites and countries being added. The 464-patient study is over 50%
enrolled and is expected to deliver top-line data in the second
quarter of 2021.
The global Phase 2/3 study recently underwent a positive DSMB
futility review, which is suggestive that the study has the
potential for a positive outcome. RedHill recently announced
positive top-line safety and efficacy data from the non-powered
U.S. Phase 2 study with opaganib in patients with COVID-19
pneumonia, in which opaganib demonstrated greater improvement in
reducing oxygen requirement by end of treatment on Day 14 across
key primary and secondary efficacy outcomes. The Phase 2 data also
showed no material safety differences between the opaganib and
placebo treatment arms - further adding to the growing safety
database for opaganib.
Opaganib is a novel, orally-administered sphingosine kinase-2
(SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and
anti-thrombotic activity, that targets a human cell component
involved in viral replication and is therefore expected to be
effective against emerging viral variants with mutations in the
spike protein.
About Opaganib (Yeliva®, ABC294640)
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[3], 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) RHB-204, with an
ongoing Phase 3 study for pulmonary nontuberculous mycobacteria
(NTM) disease; (ii) opaganib (Yeliva®,
ABC294640), a first-in-class SK2 selective
inhibitor targeting multiple indications with positive Phase 2
COVID-19 data and an ongoing 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 in a U.S. Phase 2/3 study as treatment for 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.
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 and includes statements regarding the timing of
the reporting of a full analysis of the data from the U.S. Phase 2
trial evaluating opaganib, the timing of potential emergency use
applications for opaganib and the timing of reporting of top-line
data for the global Phase 2/3 study with opaganib. 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 Company's COVID-19 Phase 2/3 study evaluating opaganib
will not be successful; the risk of a delay in receiving top-line
data from the Phase 2/3 study and in receiving data to support
emergency use applications or in making such emergency use
applications, if at all; the risk that data received from the Phase
2/3 study, even if successful, will not be sufficient to support
filing or approval of emergency use applications or other marketing
applications in certain or all geographical regions; the risk that
the full analysis of data from the U.S. Phase 2 clinical study
evaluating opaganib will be delayed or will differ from the
preliminary data; the risk that the Company will not initiate the
Phase 2/3 study for opaganib in certain geographies, will not
expand this study to additional countries and that it will not be
successful and that enrollment will be delayed; the risk that the
Phase 2/3 study will not provide a clear picture of opaganib's
potential in treating severe COVID-19; the risk that other COVID-19
patients treated with opaganib will not show any clinical
improvement; the development risks of early-stage discovery efforts
for a disease that is still little understood, including difficulty
in assessing the efficacy of opaganib for the treatment of severe
COVID-19, if at all; intense competition from other companies
developing potential treatments and vaccines for COVID-19; the
effect of a potential occurrence of patients suffering serious
adverse events using opaganib, as well as 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 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
Movantik®, 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 and sustain 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,
preclinical 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 commercial products 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 events 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 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.
References:
[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.
Company
contact:
|
Media
contacts:
|
Adi Frish
|
U.S.: Bryan
Gibbs, Finn Partners
|
Chief Corporate &
Business Development Officer
|
+1 212 529
2236
|
RedHill
Biopharma
|
bryan.gibbs@finnpartners.com
|
+972-54-6543-112
|
UK: Amber
Fennell, Consilium
|
adi@redhillbio.com
|
+44 (0) 7739 658
783
|
|
fennell@consilium-comms.com
|
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SOURCE RedHill Biopharma Ltd.