TEL AVIV, Israel and
RALEIGH,
N.C. , Feb.
7, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:
RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical
company, today announced results from two recently completed
prespecified analyses from the oral opaganib
(ABC294640)[1] Phase 2/3 study in hospitalized severe
COVID-19. The first analysis showed that opaganib significantly
reduced mortality when given to patients who received remdesivir
and corticosteroids, the best available standard-of-care (SoC) for
hospitalized patients. A second analysis further showed that
opaganib delivered a significant benefit in time to recovery,
defined as achieving a score of 1 or less on the WHO Ordinal Scale
by Day 14. The Company is advancing regulatory discussions in
multiple countries, with potential emergency and marketing
authorization applications being planned for certain countries in
the first half of 2022.
The prespecified mortality analysis, undertaken for all patients
from the Phase 2/3 study who were receiving remdesivir and
corticosteroids at baseline, demonstrated a significant 70.2%
mortality benefit for opaganib-treated patients, with a mortality
rate of 6.98% (n=3/43) for the opaganib arm + SoC versus 23.4%
(n=11/47) for placebo + SoC by Day 42 (p-value=0.034).
The second prespecified analysis showed opaganib delivered a
significant 34% benefit in time to recovery, defined as achieving a
score of 1 or less on the WHO Ordinal Scale by Day 14, with 37.4%
of opaganib-treated patients (n=86/230) reaching this event versus
27.9% of patients (n=65/233) treated with placebo + SoC
(p-value=0.013, Hazard Ratio 1.49).
"These prespecified analyses, along with the recent data showing
opaganib's improved median time to viral RNA clearance, provide
strong support for the promising results observed in the Phase 2/3
study post-hoc analysis. Oral opaganib has now shown an ability to
reduce deaths, speed up recovery and clear viral RNA, all with a
safety and tolerability profile similar to placebo. Strikingly,
opaganib has delivered these benefits over and above the very best
level of current standard-of-care, with patients receiving both
remdesivir and corticosteroids," said Dr. Mark Levitt, RedHill's Chief Scientific
Officer. "The hospitalized moderate to severe COVID-19 patient
group is estimated to represent more than 50% of all hospitalized
COVID-19 cases and growing. The prevalence of Omicron, new
emerging variants, loss of efficacy of existing drugs against such
variants and the difficulty in stopping COVID-19 early enough in
its course, despite the availability of new drugs, all point very
clearly to the urgent need for new, preferably orally-administered,
therapeutic options, unaffected by spike protein mutations, for
this underserved and substantial patient population."
Regulatory progress continues to be made, with opaganib data
submissions initiated in the fourth quarter of 2021 in the U.S.,
Europe, UK and additional
countries. Discussions remain ongoing and initial guidance on a
confirmatory study and potential path to approval has been received
from the EU's EMA, the U.S. FDA, UK's MHRA and others. Based on
regulatory feedback from other territories and external advice
received, the Company is also planning potential emergency and
marketing authorization applications in certain such countries in
the first half of 2022.
Oral 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 a
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).
Additionally, results from a post-hoc analysis of data from 251
study participants requiring a Fraction of inspired Oxygen (FiO2)
up to and including 60% at baseline (54% of the study participants)
demonstrated that treatment with oral opaganib resulted in a 62%
reduction in mortality as well as improved outcomes in time to room
air, median time to hospital discharge, and likelihood of
intubation and mechanical ventilation in this large group of
hospitalized, moderately severe COVID-19 patients.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary,
first-in-class, orally-administered, sphingosine kinase-2 (SK2)
selective inhibitor, with proposed dual anti-inflammatory and
antiviral activity. Opaganib is host-targeted and is expected to be
effective against emerging viral variants, having already
demonstrated inhibition against variants of concern, including
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.
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 COVID-19 and Phase 2 studies for prostate cancer and
cholangiocarcinoma ongoing; (iii) RHB-107
(upamostat), an oral 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 , 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 potential emergency and
marketing authorization applications in certain ex-U.S. countries
in the first half of 2022. 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 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 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. / 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] 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.