TEL AVIV, Israel and
RALEIGH, N.C., March 22, 2021 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced that it has acted on a
request to provide opaganib[1] treatment on an
outpatient basis under compassionate use exemption for several
Swiss patients suffering from COVID-19 pneumonia.
Acting rapidly to ensure emergency transport and supply of drug,
treatment was initiated with orally-administered opaganib within
the past week. Opaganib is a novel, orally-administered sphingosine
kinase-2 (SK2) inhibitor with demonstrated dual anti-inflammatory
and antiviral activity, targeting a human cell component involved
in viral replication and therefore expected to be effective against
emerging viral variants with mutations in the spike protein.
Gilead Raday, RedHill's Chief
Operating Officer, said: "We continue to do all we can to
support patients, and their treating physician, who are in need of
treatment options for COVID-19. Having recently reported positive
Phase 2 data with opaganib in the U.S., our ongoing global
464-patient Phase 2/3 study with opaganib for severe COVID-19 is
now more than two thirds enrolled."
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 advancing in a total of eight
countries and 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.
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. 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 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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