Independent Data Safety Monitoring Board unanimously
recommends continuation of the global Phase 2/3 study of
orally-administered opaganib in severe COVID-19 pneumonia based on
review of unblinded safety data from the first 255 treated
patients
The 464-patient global Phase 2/3 COVID-19 study is over 75%
enrolled, with completion of enrollment expected in the coming
weeks
Opaganib potentially minimizes likelihood of resistance due
to viral mutations by targeting a human cell component involved in
viral replication
TEL AVIV, Israel and
RALEIGH, N.C., April 9, 2021 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced that the global Phase
2/3 study with orally-administered opaganib (Yeliva®,
ABC294640)[1] in patients hospitalized with severe COVID-19
pneumonia has received a unanimous recommendation to continue,
following a fourth independent Data Safety Monitoring Board (DSMB)
safety review. The DSMB's recommendation is based on an analysis of
unblinded safety data from the first 255 patients treated for 14
days, extending the total opaganib safety database to approximately
380 patients.
Mark L. Levitt, M.D., Ph.D.,
Medical Director at RedHill, said: "With approximately 380
patients in the opaganib safety database following this positive
fourth DSMB review, we are building a clear picture of the safety
profile of opaganib." Dr. Levitt continued: "Moreover,
adding together the positive Phase 2 data, the successful DSMB
futility reviews and the outcomes from compassionate use of
opaganib, we look forward with optimism to the reporting of
top-line data from the Phase 2/3 study, which will provide the
clearest indication to date of opaganib's promise in treating
COVID-19."
The global Phase 2/3 randomized, double-blind, parallel-arm,
placebo-controlled study of opaganib in patients with severe
COVID-19 pneumonia requiring hospitalization and treatment with
supplemental oxygen (NCT04467840), is over 75% enrolled in
approximately 40 recruiting sites.
RedHill recently announced positive top-line safety and efficacy
data from the non-powered U.S. Phase 2 study with opaganib in 40
patients with COVID-19 pneumonia, in which opaganib demonstrated
greater improvement in reducing oxygen requirement by end of
treatment on Day 14, on top of standard-of-care. The Phase 2 data
also showed no material safety differences between the opaganib and
placebo on top of standard-of-care treatment arms - further adding
to the growing safety database for opaganib.
To find out more about RedHill Biopharma's Expanded Access
policy, please visit: www.redhillbio.com/expandedaccess.
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 40-patient U.S. Phase 2 study.
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. Additionally, preclinical in vivo
studies have demonstrated opaganib's potential to ameliorate
inflammatory lung disorders, such as pneumonia, and mitigate
pulmonary fibrotic damage, and has shown 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[2].
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. 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
the risk of a delay in top-line data from the Phase 2/3 COVID-19
study, that such a study may not be successful, that opaganib will
not be effective against emerging viral variants 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 18, 2021. 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
contacts:
U.S.: Bryan
Gibbs, Finn Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
UK: Amber
Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.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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