TEL AVIV, Israel and
RALEIGH, NC, June 21, 2021 /CNW/ -- RedHill Biopharma Ltd.
(Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced presentation of the
positive Phase 2 safety and efficacy data for oral opaganib
(Yeliva®, ABC294640)[1] in hospitalized patients with COVID-19
pneumonia at the World Microbe Forum (WMF) 2021 (poster #:
5574).
Results and post hoc analyses of data from the 40-patient U.S.
Phase 2 study were presented in a poster entitled, "Opaganib, an
Oral Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: A
Randomized, Double-blind, Placebo-controlled Phase 2A Study, in
Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia
(NCT: 04414618)"[2]. Patients in the study were
randomized to receive either opaganib or placebo in addition to
standard of care (SoC), predominantly including dexamethasone
and/or remdesivir. Findings include:
- 50% of patients treated with opaganib (n=22) reached room air
by Day 14 compared to 22% in the placebo group (n=18). The benefit
of reaching room air by Day 14 for patients on opaganib was
maintained regardless of whether the patients were receiving
dexamethasone and/or remdesivir
- 86.4% of patients treated with opaganib were discharged from
hospital by Day 14 compared to 55.6% of patients treated with
placebo
- Median time to discharge was 6 days for the opaganib group
compared to 7.5 days for the placebo group
- 81.8% of opaganib patients achieved a 2-point improvement in
the WHO Ordinal Scale compared to 55.6% of patients in the placebo
group – achieved in a median time of 6 days versus 7.5 days,
respectively
- No significant differences in safety-related measures between
the two groups (with diarrhea being the main treatment-emergent
difference in tolerability)
"The need for an effective oral therapy to treat COVID-19 is
clear. Such a therapy would greatly improve our ability to manage
this pandemic," said Kevin
Winthrop, MD, MPH, Professor of Infectious Diseases at
Oregon Health & Science University, who presented the findings
at WMF. "These data, from this proof-of-concept clinical study
of opaganib in patients with severe COVID-19, suggest a potential
role of SK2 inhibition in combating the effects of this virus. With
much more data on opaganib expected in the coming weeks, we could
make some real progress toward having access to a much-needed oral
therapy for patients who currently have a paucity of options
available to them."
"Presentation of these positive data from our exploratory Phase
2 study support our growing confidence that opaganib could be the
first novel, oral therapy to demonstrate efficacy in the treatment
of COVID-19 in a large late-stage study. With the recent completion
of enrollment of our 475-patient global Phase 2/3 study, we will
have a clearer picture of that in the very near future," said
Mark L. Levitt, MD, Ph.D., Medical
Director at RedHill. "Opaganib acts on both the cause and
effect of COVID-19 via a unique dual antiviral and
anti-inflammatory mode of action. Being host-targeted, opaganib is
also expected to maintain effect against the emerging SARS-CoV-2
variants, which continue to threaten the progress being made
against the pandemic and underscore the urgent need for effective
COVID-19 therapeutics."
The global 475-patient Phase 2/3 study of opaganib in severe
COVID-19 has been approved in 10 countries and completed
enrollment, through 57 participating sites, on June 6th. The primary endpoint of the
study is the proportion of patients breathing room air without
oxygen support by Day 14. Additional important outcome measures,
such as time to discharge from hospital, improvement according to
the World Health Organization Ordinal Scale for Clinical
Improvement and incidence of intubation and mortality, will also be
captured in the follow-up period of up to 6 weeks. The study
received four independent DSMB recommendations to continue
following unblinded safety reviews and a futility review.
Additionally, an evaluation of the blinded blended intubation and
mortality rates to date was encouraging as compared to reported
rates of mortality from large platform studies such as RECOVERY,
and other studies in similar patient populations[3].
About Opaganib (Yeliva®, ABC294640)
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, which recently completed
enrollment, and has demonstrated positive safety and efficacy
signals in preliminary top-line data from the 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 has shown
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[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 (Yeliva®,
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 last patient visit and 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
|
[1] Opaganib is an investigational new drug, not available for
commercial distribution.
[2] Opaganib, an Oral Sphingosine Kinase-2 (SK2) Inhibitor in
COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled
Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2
Positive Pneumonia (NCT: 04414618). K. L. Winthrop, A. W. Skolnick,
A. M. Rafiq, S. H. Beegle, J. Suszanski, G. Koehne,
O.Barnett-Griness, A. Bibliowicz, R. Fathi, P. Anderson, G. Raday,
G. Eagle, V. Katz Ben-Yair, H. S.
Minkowitz, M. L. Levitt, M. S. Gordon
[3] Based on preliminary blinded blended data from 463 patients.
The Company did not conduct a head-to-head comparison study in the
same patient population. The theoretical comparison between the
global Phase 2/3 study with opaganib and reported rates of
mortality from large platform studies such as RECOVERY, and other
studies in similar patient populations, serves as a general
benchmark and should not be construed as a direct and/or applicable
comparison as if the Company conducted a head-to-head comparison
study.
[4] 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.
[5] Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
[6] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[7] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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SOURCE RedHill Biopharma Ltd.