RedHill adds two more
manufacturing partners, both U.S.-based, for large-scale
manufacturing of opaganib, in preparation for potential emergency
use applications as early as Q1/2021
The new collaborations follow recently announced
collaborations with European and Canadian manufacturers
U.S. Phase 2 study fully enrolled – top-line data expected in
the coming weeks; parallel global Phase 2/3 study more than 50%
enrolled – top-line data expected Q1/2021
Opaganib's promising novel mechanism of action potentially
minimizes likelihood of resistance due to viral
mutations
TEL AVIV, Israel and
RALEIGH, N.C., Nov. 25, 2020 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or
the "Company"), a specialty biopharmaceutical company, today
announced partnerships with two leading, U.S.-based manufacturers
for large-scale manufacturing of opaganib[1]. These collaborations
further advance ongoing preparations to support potential emergency
use applications for opaganib to treat severe COVID-19 pneumonia,
expected as early as the first quarter of 2021. The new
collaborations follow recently announced collaborations with
European and Canadian manufacturers.
"We are expanding our U.S.-based manufacturing capacity for
orally administered opaganib, ahead of potential emergency use
applications as early as Q1/2021," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Together
with our recently announced similar partnerships in Europe and Canada and in light of our rapidly progressing
Phase 2/3 opaganib COVID-19 program, these new U.S. partnerships
better place RedHill to meet
potential demand for opaganib, if approved."
Opaganib is a novel, orally administered, sphingosine kinase-2
(SK2) selective inhibitor with demonstrated dual anti-inflammatory
and antiviral activity that acts on the cause and effect of
COVID-19 disease, targeting a host cell component involved in viral
replication, potentially minimizing likelihood of resistance due to
viral mutations.
Enrollment in the 270-patient global Phase 2/3 study with
opaganib in patients with severe COVID-19 pneumonia
(NCT04467840) is more than 50% complete. The study is approved in
six countries and is on track to deliver top-line data in the first
quarter of 2021. This study is focused on and powered for efficacy
evaluation, and recently received a unanimous recommendation to
continue by an independent Data and Safety Monitoring Board (DSMB),
following a pre-scheduled safety review of the first 70 patients to
have been treated for 14 days. A prescheduled, unblinded futility
interim analysis will also be conducted by the DSMB in the coming
weeks, evaluating data from the first 135 subjects that have
reached the primary endpoint.
The parallel U.S. Phase 2 study with opaganib (NCT04414618) has
completed enrollment of all 40 subjects, with topline data expected
in the coming weeks. This study is not powered for efficacy and is
focused on safety evaluation and identification of efficacy
signals.
About Opaganib (ABC294640, Yeliva®)
Opaganib, a new chemical entity, is a proprietary,
first-in-class, orally administered, sphingosine kinase-2 (SK2)
selective inhibitor with demonstrated dual anti-inflammatory and
antiviral activity that targets a host cell component, potentially
minimizing the likelihood for resistance due to viral mutations.
Opaganib has also shown anticancer activity and has the potential
to target multiple oncology, viral, inflammatory and
gastrointestinal indications.
Opaganib is being evaluated in a global Phase 2/3 study and a
U.S. Phase 2 study for the treatment of severe COVID-19 pneumonia.
Opaganib 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.
Preclinical data have demonstrated both anti-inflammatory and
antiviral activities of opaganib, with the potential to reduce
inflammatory lung disorders, such as pneumonia, and mitigate
pulmonary fibrotic damage. 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[2] have demonstrated that
opaganib decreased fatality rates from influenza virus infection
and ameliorated Pseudomonas aeruginosa-induced lung injury
by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar
lavage fluids.
Opaganib was originally developed by U.S.-based Apogee
Biotechnology Corp. and completed multiple successful preclinical
studies in oncology, inflammation, GI, and radioprotection models,
as well as a Phase 1 clinical study in cancer patients with
advanced solid tumors and an additional Phase 1 study in multiple
myeloma.
Under a compassionate use program, patients with severe COVID-19
(as classified by the WHO ordinal scale) were treated with opaganib
in a leading hospital in Israel.
Data from the treatment of these first patients with severe
COVID-19 with opaganib have been published[3]. Analysis of
treatment outcomes suggest substantial benefit to patients treated
with opaganib under compassionate use in both clinical outcomes and
inflammatory markers as compared to a retrospective matched
case-control group from the same hospital. All patients in the
opaganib-treated group were discharged from hospital on room air
without requiring intubation and mechanical ventilation, whereas
33% of the matched case-control group required intubation and
mechanical ventilation. Median time to weaning from high-flow nasal
cannula was reduced to 10 days in the opaganib-treated group, as
compared to 15 days in the matched case-control group.
The development of opaganib has been supported by grants
and contracts from U.S. federal and state government agencies
awarded to Apogee Biotechnology Corp., including from the NCI,
BARDA, the U.S. Department of Defense and the FDA Office of Orphan
Products Development.
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[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 (Yeliva®), a
first-in-class 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-104, with positive results from a first Phase 3
study for Crohn's disease; (iv) 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; (v) RHB-107
(upamostat), a Phase 2-stage serine protease inhibitor with
a planned Phase 2/3 study in symptomatic COVID-19 and targeting
multiple other cancer and inflammatory gastrointestinal
diseases; and (vi) RHB-106, an encapsulated
bowel preparation. More information about the Company is available
at www.redhillbio.com.
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 statements regarding the timing of the
reporting of data from the U.S. Phase 2 trial evaluating opaganib,
the timing, if at all, of potential emergency use applications of
opaganib and reporting of data, from the global Phase 2/3 study
with opaganib and regarding the planned Phase 2/3 study for
RHB-107 in symptomatic COVID-19 patients. 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, without limitation, the risk
that the Company's Phase 2/3 study evaluating opaganib will not be
completed or successful; the risk of a delay in receiving data from
the Phase 2/3 study with opaganib or delay in making emergency use
applications, if at all; the risk that the U.S. Phase 2 clinical
study evaluating opaganib will not be successful and the risk that
the reporting of data from this clinical study will be delayed if
at all; the risk that the planned Phase 2/3 study for
RHB-107 in symptomatic COVID-19 patients will not
occur, will be delayed or will not be completed or successful; the
risk that other COVID-19 patients treated with opaganib or RHB-107
will not show any or insufficient clinical improvement; the
development risks of early-stage discovery efforts for a disease
that is still little understood, including difficulty in assessing
the efficacy of opaganib and RHB-107 for the treatment of COVID-19,
if at all; intense competition from other companies developing
potential treatments and vaccines for COVID-19; the effect of a
potential occurrence of patients suffering serious adverse events
using opaganib under compassionate use programs; the risk that the
ongoing Phase 3 study for pulmonary nontuberculous mycobacteria
(NTM) disease will be delayed, not be completed, or will not be
successful, 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 lack of sufficient
financial resources which may result in material adverse impact on
the Company's research, manufacturing, preclinical studies,
clinical trials, and other therapeutic candidate development
activities including delay or termination of preclinical or
clinical activities or of any other such activities (iii) the
Company's ability to advance its therapeutic candidates into
clinical trials or to successfully complete its preclinical studies
or clinical trials (iv) 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; (v) the manufacturing, clinical development,
commercialization, and market acceptance of the Company's
therapeutic candidates and Talicia®; (vi) the Company's
ability to successfully commercialize and promote
Movantik®, Talicia® and Aemcolo®;
(vii) the Company's ability to establish and maintain corporate
collaborations; (viii) 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; (ix) 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; (x) the implementation of
the Company's business model, strategic plans for its business and
therapeutic candidates; (xi) 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; (xii) parties from whom the Company
licenses its intellectual property defaulting in their obligations
to the Company; (xiii) estimates of the Company's expenses, future
revenues, capital requirements and needs for additional financing;
(xiv) the effect of patients suffering adverse events using
investigative drugs under the Company's Expanded Access Program;
and (xv) 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 4, 2020. 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 contact
(U.S.):
Bryan
Gibbs
Vice
President
Finn
Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
|
[1] Opaganib (Yeliva, ABC294640) is an investigational new drug,
not commercially available
[2] 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.
[3] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate
Use of Opaganib For Patients with Severe COVID-19. medRxiv
2020.06.20.20099010; doi:
https://doi.org/10.1101/2020.06.20.20099010
[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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