RedHill Biopharma
Announces Last Patient Out for
Phase 2/3
COVID-19
Study
of
Oral Opaganib
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 -- InvestorsHub NewsWire
-- 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