TEL AVIV, Israel and
RALEIGH, N.C., June 28, 2021 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced preliminary
results of a new preclinical study showing potent inhibition of
COVID-19 variants of concern by opaganib (Yeliva®,
ABC294640)[1].
Opaganib, a leading novel investigational oral pill in
development for the treatment of COVID-19, is a unique
host-targeted, dual antiviral and anti-inflammatory drug that acts
on the cause and effect of COVID-19. It exerts its antiviral effect
by selectively inhibiting sphingosine kinase-2 (SK2), a key enzyme
produced in human cells that can be recruited by the virus to
support its replication. Following the recently presented positive
U.S. Phase 2 study data, opaganib's global 475-patient Phase 2/3
study in hospitalized patients with COVID-19 is fully enrolled and
is expected to be completed in the coming weeks.
Working with the University of
Louisville Center for Predictive Medicine, opaganib was
studied in a 3D tissue model of human bronchial epithelial cells
(EpiAirway™) to evaluate the in vitro efficacy of opaganib
in inhibiting the Beta (South African) and Gamma
(Brazilian) SARS-CoV-2 variants. Preliminary results showed potent
inhibition of both the Beta and Gamma variants by
opaganib at non-cytotoxic doses.
"The results we have seen with opaganib so far are exciting,"
said William Severson, Ph.D.,
Director of Shared Resources for the Center for Predictive
Medicine, University of
Louisville. "They provide further evidence in
support of opaganib's antiviral capabilities and highlight
opaganib's potential as an orally-administered treatment for
COVID-19 and its continuously emerging variants."
"Opaganib inhibits an enzyme in the COVID-19 patients' cells
called sphingosine kinase-2, which the SARS-CoV-2 virus can recruit
in order to replicate," said Reza
Fathi, PhD., RedHill's Senior VP, R&D. "Opaganib's
dual antiviral and anti-inflammatory mechanism of action is
independent of mutations in the spike protein. This means we expect
opaganib to similarly work against other emerging COVID-19
variants, including the Delta (Indian) variant. Moreover, we
are looking forward to seeing the top-line clinical data from the
global Phase 2/3 study which is expected to be completed in the
coming weeks."
The global Phase 2/3 study of opaganib in COVID-19 has
previously received four independent DSMB recommendations to
continue following unblinded safety reviews and a futility review.
Additionally, an evaluation of the blinded blended intubation and
mortality rates to date was encouraging as compared to reported
rates of mortality from large platform studies such as RECOVERY,
and other studies in similar patient populations[2].
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 is host-targeted and is therefore expected to be
effective against emerging viral variants.
Opaganib is being evaluated as a treatment for COVID-19
pneumonia in a global Phase 2/3 study, which recently completed
enrollment, and has demonstrated positive safety and efficacy
signals in preliminary top-line data from the 40-patient U.S. Phase
2 study.
Opaganib demonstrated potent inhibition of viral replication
against SARS-CoV-2, the virus that causes COVID-19, 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].
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.
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[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 delay in last patient visit and top-line data from the Phase
2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study
for opaganib may not be successful and, even if successful, such
study 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 by regulatory authorities to support such potential
applications and the use or marketing of opaganib for COVID-19
patients, 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] Based on preliminary blinded blended data from 463 patients.
The Company did not conduct a head-to-head comparison study in the
same patient population. The theoretical comparison between the
global Phase 2/3 study with opaganib and reported rates of
mortality from large platform studies such as RECOVERY, and other
studies in similar patient populations, serves as a general
benchmark and should not be construed as a direct and/or applicable
comparison as if the Company conducted a head-to-head comparison
study.
[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