Patient follow-up completed for the 475-patient global Phase
2/3 study of oral opaganib for severe COVID-19
Top-line results expected in the coming weeks
Opaganib, a novel, dual antiviral and anti-inflammatory
investigational COVID-19 pill, demonstrated potent
inhibition of Beta and Gamma variants and is expected to be
effective against emerging variants, including Delta and Delta
Plus
TEL AVIV, Israel and
RALEIGH, NC, July 19, 2021 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
pharma company that is a leader in the development of novel oral
therapies for COVID-19, today announced that all treatment and
follow-up has now been completed in the 475-patient global Phase
2/3 study with opaganib (ABC294640)[1] in patients
hospitalized with severe COVID-19 pneumonia (NCT04467840). Top-line
results are expected in the coming weeks.
Opaganib is a novel, host-targeted, dual antiviral and
anti-inflammatory investigational pill in advanced clinical
development for the treatment of severe COVID-19. Opaganib recently
demonstrated potent in vitro inhibition of the Beta
(South African) and Gamma (Brazilian) variants and based on
its unique host-targeted mechanism and the preliminary results from
this study, we believe opaganib is likely to also maintain its
activity against emerging variants, including Delta and
Delta Plus. Positive U.S. Phase 2 efficacy data has also
previously been announced.
"Emerging data is showing that variants are capable of evading
vaccines' effects. Not only does this threaten efforts to control
the pandemic, but it also brings into sharp focus the urgent need
for effective oral COVID-19 therapies capable of working despite
the emergence of variants. This makes the completion of this study
even more significant, given its potential to be a game-changer in
the treatment of COVID-19," said Mark L.
Levitt, MD, Ph.D., Medical Director at RedHill. "We can
now concentrate on getting all the data collected, cleaned and
collated in the database ready for analysis and subsequent
reporting. This means we are weeks away from knowing if we are a
big step closer to having a paradigm-shifting oral therapy for
hospitalized COVID-19 patients."
The primary endpoint of the global Phase 2/3 study, approved in
10 countries, is the proportion of patients breathing room air
without oxygen support by Day 14. The study has also captured
additional important outcome measures, such as the time to hospital
discharge, improvement according to the World Health Organization
Ordinal Scale for Clinical Improvement and incidence of intubation
and mortality.
Evaluations of blinded blended intubation and mortality rates
from the Phase 2/3 study have been encouraging compared to reported
rates of mortality from large platform studies such as RECOVERY,
and other studies in similar patient populations[2].
Furthermore, four independent DSMB recommendations to continue the
study have been received following three unblinded safety reviews
and an unblinded futility analysis. Additionally, encouraging use
of opaganib under compassionate use exemption has been experienced
in Israel and Switzerland.
The Company maintains ongoing discussions with the FDA, EMA and
other regulators, on potential pathways to approval, with next
steps to be guided by study results. Discussions are also ongoing
with potential partners who are interested in the rights to
opaganib in various countries.
About Opaganib (ABC294640[3])
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 has also shown
anticancer activity and has the potential to target multiple
oncology, viral, inflammatory, and gastrointestinal
indications.
Opaganib is being evaluated as a treatment for COVID-19
pneumonia in a global Phase 2/3 study that has now completed
patient treatment and follow-up. Opaganib has also demonstrated
positive safety and efficacy signals in preliminary top-line data
from a 40-patient U.S. Phase 2 study.
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.
Opaganib demonstrated potent antiviral activity against
SARS-CoV-2, the virus that causes COVID-19, completely
inhibiting viral replication 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 have shown
decreased fatality rates from influenza virus infection and
amelioration of Pseudomonas aeruginosa-induced lung injury
by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar
lavage fluids[4].
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[5], Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in
adults[6], and Aemcolo® for
the treatment of travelers' diarrhea in
adults[7]. 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 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 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-hear comparison
study.
[3] Yeliva remains the prospective brand name for opaganib
[4] 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.
[5] Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
[6] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[7] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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