TEL AVIV, Israel and
RALEIGH, N.C., Dec. 22, 2020 /CNW/ -- RedHill Biopharma Ltd.
(Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced that the global Phase
2/3 study with orally-administered opaganib (Yeliva®,
ABC294640)[1] in patients hospitalized with severe
COVID-19 pneumonia has received a second unanimous recommendation
to continue, following a second independent Data Safety Monitoring
Board (DSMB) safety review. The DSMB's recommendation is based on
an analysis of unblinded safety data from the first 155 patients
treated for 14 days.
"This second unanimous independent DSMB recommendation to
continue the global Phase 2/3 study of opaganib in patients with
severe COVID-19 confirms the safety of opaganib and means we can
continue to focus on completing enrollment for this study as
rapidly as possible, with a view to having top-line data in the
first quarter of 2021. If successful, we expect to make subsequent
global emergency use applications the same quarter," said
Mark L. Levitt, M.D., Ph.D.,
Medical Director at RedHill.
Enrollment in the 270-patient global Phase 2/3 study of
orally-administered opaganib in hospitalized patients with severe
COVID-19 pneumonia (NCT04467840) is more than 60% complete, 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. A
pre-scheduled, unblinded futility interim analysis will 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 top-line data
expected by year's end. This study is not powered for efficacy and
is focused on safety evaluation and potential identification of
preliminary efficacy signals.
Opaganib is a novel, orally-administered, sphingosine kinase-2
(SK2) selective inhibitor with a preclinically demonstrated
triple-action mechanism that inhibits viral replication, reduces
hyper-immune inflammatory response and diminishes ARDS-related
thrombosis (blood clots) – a dangerous complication of COVID-19
disease – in effect acting on the cause and effect of COVID-19
disease. Opaganib's target is a human host cell component involved
in viral replication, potentially minimizing the likelihood of
resistance due to viral mutations.
About Opaganib (ABC294640, Yeliva®)
Opaganib, a new chemical entity, is a proprietary,
first-in-class, orally-administered, sphingosine kinase-2 (SK2)
selective inhibitor with a demonstrated unique triple-action effect
on the pathophysiological processes associated with COVID-19
disease, 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 suggests 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 / 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 and include statements regarding the timing of the
reporting of data from the U.S. Phase 2 trial evaluating opaganib,
and 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. 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 other
COVID-19 patients treated with opaganib 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 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 is an investigational new drug, not
available for commercial distribution.
[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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SOURCE RedHill Biopharma Ltd.