RedHill Biopharma Ltd Announces Potent Omicron
Inhibition with RedHill's Opaganib
Oral opaganib's
reported potent in vitro activity against Omicron adds to previously observed inhibition of Delta
and other SARS-CoV-2 variants of
concern that cause COVID-19; Testing conducted by The University of Hong Kong School of Public
Health, a world renowned WHO collaborating center
--
Based on the new and previously
announced data, opaganib's unique human host-targeted, dual
antiviral and anti-inflammatory suggested mechanism is expected to
act independently of viral spike protein mutations and remain
effective against Omicron sub-variants BA.2, XE and other emerging
and future variants
--
Previously reported
phase 2/3 clinical data showed reduced mortality in key
subpopulations, improved viral RNA clearance, and faster time to
recovery for moderate to severe hospitalized patients treated with
opaganib
--
Regulatory
submissions and discussions in the U.S., Europe, UK and additional
countries are progressing regarding confirmatory data requirements
and pathways to potential approval
TEL AVIV, Israel and
RALEIGH, NC -- April 11, 2022 -- InvestorsHub NewsWire
-- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today announced study results in which opaganib
(ABC294640)[1],
a leading oral drug candidate for hospitalized patients with
moderate to severe COVID-19, was observed to have potent
in vitro efficacy against
the Omicron
SARS-CoV-2 variant, while maintaining host cell viability.
Based on the new and previously announced data, opaganib's unique
human host-targeted, dual antiviral and anti-inflammatory suggested
mechanism is expected to act independently of viral spike protein
mutations and remain effective against Omicron sub-variants
BA.2, XE and other emerging and future
variants.
Work on testing opaganib against Omicron was conducted by
the Centre for Immunology and
Infection (C2i), The University of Hong Kong's world-renowned
infectious diseases research center, School of Public Health, by
Dr. Michael Chan, Principal Investigator, of the Centre for
Immunology and Infection, who said: "The results of
this study showed opaganib exerting potent inhibition of
Omicron SARS-CoV-2
variant viral replication in a model that we believe
comes as close as currently possible to representing the
Omicron clinical
pathophysiological pathway. These are highly promising results that
lend further weight to opaganib's hypothesized host-mediated
antiviral activity and expected effect irrespective of viral
variant."
"Opaganib was tested for inhibition of
Omicron SARS-CoV-2 viral
replication using an ex
vivo human respiratory explant model, a methodology
based on the finding that Omicron has a replication advantage
in respiratory tract explants culture," said Reza Fathi, PhD., RedHill's Senior VP,
R&D. "The results of the study, led by Dr. Chan,
one of the leading experts in the field who's extensive
COVID-19-related research is widely published in top tier journals
such as Nature, are
encouraging. The results are also consistent with findings from the
Phase 2/3 study in which opaganib was shown, together with reducing
mortality in key subpopulations and improving the time to recovery,
to accelerate viral RNA clearance by more than 4 days, even in an
advanced patient population with a median of 11 days from onset of
symptoms – we believe a likely first for a novel oral therapy in
this underserved hospitalized moderate to severe COVID-19 patient
population."
Opaganib was studied in a global Phase 2/3 study in
hospitalized patients with severe COVID-19 pneumonia (NCT04467840).
In a prespecified analysis of all Phase 2/3 study patients with
positive PCR at screening[2],
opaganib improved the median time to viral RNA clearance by at
least 4 days, achieving viral RNA clearance in a median of 10 days,
while the median for clearance was not reached by the end of
14-days treatment in the placebo arm (Hazard Ratio 1.34; nominal
p-value=0.043, N=437/463). Additional prespecified
analyses in key subpopulations from the Phase 2/3 study also
demonstrated a 70% reduction in mortality and a 34% benefit in time
to recovery for patients treated with opaganib.
Regulatory submissions and discussions in the U.S., Europe,
UK and additional countries are progressing regarding confirmatory
data requirements and pathways to potential approval.
About Opaganib
(ABC294640)
Opaganib, a new chemical entity, is a proprietary,
first-in-class, orally-administered, sphingosine kinase-2 (SK2)
selective inhibitor, with suggested dual anti-inflammatory and
antiviral activity. Opaganib is host-targeted and, based on data
accumulated to date, is expected to maintain effect against
emerging viral variants, having already shown in vitro inhibition against variants
of concern, including Omicron and Delta. Opaganib has also shown
anticancer activity and positive preclinical results in renal
fibrosis, and has the potential to target multiple oncology, viral,
inflammatory, and gastrointestinal indications.
In prespecified analyses of Phase 2/3 clinical data,
oral opaganib has demonstrated improved viral RNA clearance, faster
time to recovery and significant mortality reduction in key patient
subpopulations. Opaganib previously delivered promising U.S. Phase
2 data in patients with moderate to severe COVID-19, submitted for
peer review and recently published in medRxiv.
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. Patient accrual, treatment and analysis in this
study are ongoing.
Opaganib demonstrated potent antiviral activity against
SARS-CoV-2, the virus that causes
COVID-19, inhibiting viral
replication of the original SARS-CoV-2 and variants tested to date
in an in
vitro model of human lung bronchial
tissue. Additionally,
preclinical in vivo studies
have demonstrated opaganib's potential to decrease renal fibrosis,
have shown decreased fatality rates from influenza virus infection,
and amelioration of bacteria-induced pneumonia lung injury with
reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage
fluids[3].
The ongoing clinical 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 (ABC294640), a
first-in-class oral SK2 selective
inhibitor targeting multiple indications with a Phase 2/3 program
for hospitalized COVID-19 and Phase 2 studies for prostate cancer
and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine
protease inhibitor in a Phase 2/3 study as treatment for
non-hospitalized 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
, 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/
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 include the
plan for and timing of potential emergency and marketing
authorization applications in certain ex-U.S. countries.
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 including, without
limitation that opaganib will not also maintain similar levels of
clinical activity against Omicron sub-variants BA.2, XE and other
emerging and future variants, the Phase 2/3 COVID-19 study for
opaganib and its 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 emergency and marketing authorization applications
in certain ex-U.S. countries will be delayed, that opaganib will
not be effective and will not be as 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
17, 2022. 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. / UK:
Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
|
Category: R&D