RedHill Biopharma's Oral Opaganib Significantly Improves Viral
Clearance in Phase 2/3 Study in Severely Ill Hospitalized COVID-19
Patients
In a prespecified analysis
of all Phase 2/3 study patients with positive PCR at screening,
opaganib improved the median time to viral RNA clearance by at
least 4 days; Median of 10 days for viral clearance in the opaganib
arm vs. clearance median not reached by end of 14-day treatment in
placebo arm (Hazard Ratio 1.34; nominal p-value=0.043,
N=437/463)
--
Opaganib is the first
oral novel drug candidate to show improved viral RNA clearance in
patients with severe COVID-19 pneumonia; Provides clinical evidence supporting
opaganib's potential antiviral activity
--
Results achieved in a
severely ill hospitalized patient population with a median of 11-days from onset of symptoms
- a patient population much further advanced than mild-moderate
outpatients with less than 5 days from symptom onset, for which
oral anti-viral medications have recently been approved
--
Results add to
opaganib's 62% reduction in mortality seen in a post-hoc analysis
of the Phase 2/3 study and are being provided to regulators as part
of ongoing discussions on potential pathways to approval in
multiple countries
TEL AVIV, Israel and
RALEIGH, NC, January 13, 2022 -- InvestorsHub NewsWire
-- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced new data from a
prespecified analysis of all oral opaganib's[1]
Phase 2/3 study patients with positive PCR at
screening, demonstrating that opaganib improved the median time to
viral RNA clearance by at least 4 days. Treatment with opaganib
resulted in viral RNA clearance in a median of 10 days while the
median for clearance in the placebo arm was not reached by the end
of 14-days treatment for placebo (Hazard Ratio 1.34; nominal
p-value=0.043, N=437/463).
"Opaganib is the first oral novel drug candidate to
demonstrate SARS-CoV-2 viral RNA clearance in hospitalized patients
with severe COVID-19 pneumonia. It also provides the first clinical
demonstration of opaganib's potential antiviral activity,
supporting the 62% reduction in mortality seen in the post-hoc
analysis of a large subset of patients from the Phase 2/3 study and
confirming the viral inhibition observed in preclinical testing
against Delta and
other variants" said Dr.
Mark Levitt, RedHill's Chief Scientific Officer. "It
is important to note that these results were achieved in a severely
ill hospitalized patient population and following an 11-day median
time from onset of symptoms - an entirely different patient
population from the mild-moderate outpatients with less than 5 days
from symptom onset, for whom oral antivirals have been recently
approved. It is also important to keep in mind that as opaganib's
proposed mechanism of action targets a host factor, its activity is
not expected to be affected by mutations in the spike protein
emerging with new viral variants, including Omicron."
Opaganib was studied in a global Phase 2/3 study in
hospitalized patients with severe COVID-19 pneumonia (NCT04467840)
with positive PCRs at screening obtained for 437 out of 463
patients (the remaining patients could not be included in this
prespecified analysis due to lack of PCR results at screening).
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.
RedHill is vigorously pursuing the development program
for opaganib and is in ongoing discussions with multiple regulatory
agencies regarding potential pathways to
approval.
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 strong inhibition against variants of concern,
including Delta.
Opaganib has also shown anticancer activity and positive
preclinical results in renal fibrosis, and also has the potential
to target multiple oncology, viral, inflammatory, and
gastrointestinal indications.
Opaganib previously delivered positive 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 by reducing the levels of IL-6 and TNF-alpha in
bronchoalveolar lavage fluids[2].
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[3],
Talicia®
for the treatment of Helicobacter pylori (H. pylori)
infection in adults[4],
and Aemcolo®
for the treatment of travelers' diarrhea in
adults[5].
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. 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 of regulatory feedback
regarding the opaganib Phase 2/3 data packages submitted to the
regulatory authorities, the risk
that further analysis of the top-line results of the Phase 2/3
COVID-19 study for opaganib results in findings inconsistent with
the data disclosed in this release; the risk that no further
COVID-19 studies for opaganib will be commenced, and if commenced,
may not be successful; the risk that any additional studies for
opaganib in COVID-19 patients, even if successful, will not be
sufficient for regulatory applications, including emergency use or
marketing applications, and that additional COVID-19 studies for
opaganib will be required by regulatory authorities to support such
potential applications and the use or marketing of opaganib for
COVID-19 patients, the risk 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
promoteTalicia®,Aemcolo®
and Movantik®;
(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