TEL AVIV, Israel and
RALEIGH, NC, May 26, 2021 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced receipt of two Notices
of Allowance from the U.S. Patent and Trademark Office (USPTO)
covering opaganib[1] and RHB-107
(upamostat)[2] as methods for the treatment of COVID-19
caused by the SARS-CoV-2 virus.
Both opaganib and RHB-107 are novel COVID-19 therapeutic
candidates, in oral pill form, with dual mechanism of action
effects. Both are host-targeted and are therefore expected to be
effective against emerging viral variants with various mutations in
the spike protein.
"There is an urgent need for oral COVID-19 treatments for
patients inside and outside of the hospital setting," said
Danielle T. Abramson, Ph.D., VP,
Intellectual Property & Research at RedHill. "With two
novel oral COVID-19 therapeutics in late clinical-stage
development, RedHill stands at the forefront of research for
COVID-19 treatments. We are very pleased with the new intellectual
property protection which extends until at least 2041. The Company
has also filed for protection under the Patent Cooperation Treaty
(PCT) and has the option of applying in the member countries
thereof."
Enrollment in opaganib's global Phase 2/3 study in hospitalized
patients with severe COVID-19 (NCT04467840) is almost 100%
complete. RHB-107's Phase 2/3 study is ongoing in non-hospitalized
patients with symptomatic COVID-19 (NCT04723527) who do not require
supplemental oxygen. Together, this covers potential treatment for
the vast majority of affected patients.
In view of the upcoming completion of enrollment, RedHill is
evaluating the regulatory path for opaganib with a focus on those
countries currently most affected by COVID-19. The regulatory path,
including potential submissions of emergency use applications in
those countries, is subject to whether the data generated by the
ongoing Phase 2/3 study is sufficiently positive and supportive as
well as the specific requirements in each country. The strength of
the safety and efficacy data generated from the opaganib studies
will be key to regulatory applications. Additional studies to
support the potential of such applications and the use or marketing
of opaganib are likely to be required. For example, the FDA has
indicated we will need to complete additional studies to support
applications in the U.S. Evaluations and discussions continue with
the FDA, EMA and regulators in other countries.
About Opaganib (Yeliva®, ABC294640)
Opaganib, a new chemical entity, is a proprietary,
first-in-class, orally-administered, sphingosine kinase-2 (SK2)
selective inhibitor, with 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 is 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 has also 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 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 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[3].
Originally developed by Apogee Biotechnology Corp., opaganib's
development 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 RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally-administered
potent inhibitor of several serine proteases, with antiviral and
potential tissue-protective effects. RHB-107 targets human cell
factors involved in preparing the spike protein for viral entry
into target cells and is therefore expected to be effective against
emerging viral variants with mutations in the spike protein.
RHB-107 is being evaluated in a U.S. Phase 2/3 study for treatment
of non-hospitalized patients with symptomatic COVID-19 who do not
require supplemental oxygen. In addition, RHB-107 has potential in
targeting cancer, inflammatory lung diseases and gastrointestinal
diseases. RHB-107 has undergone several Phase 1 studies and two
Phase 2 studies, demonstrating its clinical safety profile in
approximately 200 patients. RedHill acquired the exclusive
worldwide rights to RHB-107, excluding China, Hong
Kong, Taiwan and
Macao, from Germany's Heidelberg Pharmaceuticals (FSE:
HPHA) (formerly WILEX AG) for all indications.
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[4], Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in
adults[5], and Aemcolo® for
the treatment of travelers' diarrhea in
adults[6]. 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 completion of enrollment for the Phase 2/3
COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for
RHB-107, delay in top-line data from the Phase 2/3 COVID-19 study
for opaganib, that the Phase 2/3 COVID-19 study for opaganib and
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 are
likely to be required, and for RHB-107 may be required, by
regulatory authorities to support such potential applications and
the use or marketing of opaganib and/or RHB-107, as the case may
be, for COVID-19 patients, that opaganib and RHB-107 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] RHB-107 (upamostat) is an investigational new drug,
not available for commercial distribution.
[3] 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.
[4] Full prescribing information for
Movantik® (naloxegol) is available at:
www.Movantik.com.
[5] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[6] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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SOURCE RedHill Biopharma Ltd.