TIDMRDHL
RedHill Biopharma Ltd
11 April 2022
Press Release
RedHill Reports Potent Inhibition of Omicron with Oral COVID-19
Drug Candidate Opaganib In Vitro
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, 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(R) for opioid-induced constipation in adults[4],
Talicia(R) for the treatment of Helicobacter pylori (H. pylori)
infection in adults[5], and Aemcolo(R) 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(R) ;
(v) the Company's ability to successfully commercialize and promote
Movantik(R) , Talicia(R) and Aemcolo(R) ; (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: Media contacts:
Adi Frish U.S. / UK: Amber Fennell, Consilium
Chief Corporate & Business Development +44 (0) 7739 658 783
Officer fennell@consilium-comms.com
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: R&D
[1] Opaganib is an investigational new drug, not available for
commercial distribution.
[2] Positive PCRs at screening obtained for 437 out of 463
patients - remaining patients could not be included in this
prespecified analysis due to lack of PCR results at screening
[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] Movantik(R) (naloxegol) is indicated for opioid-induced
constipation (OIC). Full prescribing information see:
www.movantik.com.
[5] Talicia(R) (omeprazole magnesium, amoxicillin and rifabutin)
is indicated for the treatment of H. pylori infection in adults.
For full prescribing information see: www.Talicia.com.
[6] Aemcolo(R) (rifamycin) is indicated for the treatment of
travelers' diarrhea caused by noninvasive strains of Escherichia
coli in adults. For full prescribing information see:
www.aemcolo.com.
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