- 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, N.C., April 11, 2022 /PRNewswire/ -- 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 screening2, 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
fluids3.
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
adults4, Talicia® for the treatment of
Helicobacter pylori (H. pylori) infection in
adults5, and Aemcolo® for the
treatment of travelers' diarrhea in adults6. 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
[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® (naloxegol) is indicated for opioid-induced
constipation (OIC). Full prescribing information see:
www.movantik.com.
[5] Talicia® (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® (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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SOURCE RedHill Biopharma Ltd.