RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on
Top of Remdesivir and Corticosteroids in Severe
COVID-19
Updates on
Regulatory Discussions and Plans in Multiple
Countries
Prespecified
analysis of Phase 2/3 opaganib data in severe COVID-19 patients
showed a significant, 70.2% mortality benefit with opaganib by Day
42 when given on top of the best available standard-of-care (SoC),
remdesivir and corticosteroids (6.98% mortality in the opaganib arm
versus 23.4% for placebo, p-value=0.034)
--
A second
prespecified analysis showed that opaganib also delivered a
significant 34% benefit in 'time to recovery by Day 14', with 37.4%
of opaganib-treated patients reaching this event versus 27.9% of
patients treated with placebo + SoC
(p-value=0.013)
--
These additional
prespecified mortality and recovery analyses, along with previously
announced data showing opaganib's improved median time to
SARS-CoV-2 viral RNA clearance, further strengthen the positive
outcomes in the Phase 2/3 study post-hoc analysis. All data is
being shared with regulators
--
Opaganib data
submissions initiated in Q4/21, initial guidance on potential path
to approval received from the EU's EMA, the U.S. FDA, UK's MHRA and
others, discussions ongoing
--
Based on regulatory
feedback and external advice received from other territories,
potential emergency and marketing authorization applications
planned in H1/2022
TEL AVIV, Israel and RALEIGH,
NC, February 7, 2022 -- InvestorsHub NewsWire
-- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today
announced results from two recently completed
prespecified analyses from the oral opaganib
(ABC294640)[1]
Phase 2/3 study in hospitalized severe
COVID-19. The first analysis showed that opaganib significantly
reduced mortality when given to patients who received remdesivir
and corticosteroids, the best available standard-of-care (SoC) for
hospitalized patients. A second analysis further showed that
opaganib delivered a significant benefit in time to recovery,
defined as achieving a score of 1 or less on the WHO Ordinal Scale
by Day 14. The Company is advancing regulatory discussions in
multiple countries, with potential emergency and marketing
authorization applications being planned for certain countries in
the first half of 2022.
The prespecified mortality analysis, undertaken for all
patients from the Phase 2/3 study who were receiving remdesivir and
corticosteroids at baseline, demonstrated a significant 70.2%
mortality benefit for opaganib-treated patients, with a mortality
rate of 6.98% (n=3/43) for the opaganib arm + SoC versus 23.4%
(n=11/47) for placebo + SoC by Day 42
(p-value=0.034).
The second prespecified analysis showed opaganib
delivered a significant 34% benefit in time to recovery, defined as
achieving a score of 1 or less on the WHO Ordinal Scale by Day 14,
with 37.4% of opaganib-treated patients (n=86/230) reaching this
event versus 27.9% of patients (n=65/233) treated with placebo +
SoC (p-value=0.013, Hazard Ratio 1.49).
"These prespecified analyses, along with the recent
data showing opaganib's improved median time to viral RNA
clearance, provide strong support for the promising results
observed in the Phase 2/3 study post-hoc analysis. Oral opaganib
has now shown an ability to reduce deaths, speed up recovery and
clear viral RNA, all with a safety and tolerability profile similar
to placebo. Strikingly, opaganib has delivered these benefits over
and above the very best level of current standard-of-care, with
patients receiving both remdesivir and corticosteroids,"
said Dr. Mark Levitt, RedHill's
Chief Scientific Officer. "The hospitalized moderate
to severe COVID-19 patient group is estimated to represent more
than 50% of all hospitalized COVID-19 cases and growing. The
prevalence of Omicron, new emerging variants,
loss of efficacy of existing drugs against such variants and the
difficulty in stopping COVID-19 early enough in its course, despite
the availability of new drugs, all point very clearly to the urgent
need for new, preferably orally-administered, therapeutic options,
unaffected by spike protein mutations, for this underserved and
substantial patient population."
Regulatory progress continues to be made, with opaganib
data submissions initiated in the fourth quarter of 2021 in the
U.S., Europe, UK and additional countries. Discussions
remain ongoing and initial guidance on a confirmatory study and
potential path to approval has been received from the EU's EMA, the
U.S. FDA, UK's MHRA and others. Based on regulatory
feedback from other territories and external advice received, the
Company is also planning potential emergency and marketing
authorization applications in certain such countries in the first
half of 2022.
Oral opaganib was studied in a global Phase 2/3 study
in hospitalized patients with severe COVID-19 pneumonia
(NCT04467840). In a prespecified analysis of all Phase 2/3 study
patients with a positive PCR at screening[2]
opaganib improved the median time to viral
RNA clearance by at least 4 days, achieving viral RNA clearance in
a median of 10 days, while the median for clearance was not reached
by the end of 14-days treatment in the placebo arm (Hazard Ratio
1.34; nominal p-value=0.043, N=437/463). Additionally, 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.
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 inhibition against variants of concern,
including Delta. Opaganib has also shown
anticancer activity and positive preclinical results in renal
fibrosis, and has the potential to target multiple oncology, viral,
inflammatory, and gastrointestinal indications.
Opaganib previously delivered promising 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 with reduced levels of IL-6 and TNF-alpha in
bronchoalveolar lavage fluids[3].
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[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
(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 and include the
plan for potential emergency and marketing authorization
applications in certain ex-U.S. countries in the first half of
2022. 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 Phase 2/3 COVID-19 study for
opaganib and its 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 emergency and marketing authorization applications
in certain ex-U.S. countries will be delayed, 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. / UK: Amber
Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
|
Category: R&D