RedHill Biopharma Completes Enrollment of Oral Opaganib Phase 2/3 COVID-19 Study
AsiaNet 89952
TEL AVIV, Israel and RALEIGH, NC, June 7, 2021, /PRNewswire=KYODO JBN/--
- The global Phase 2/3 study of orally-administered opaganib for the treatment
of severe COVID-19 enrolled a total of 475 patients, more than the planned 464
- Opaganib is uniquely positioned as a leading novel, dual-action,
investigational COVID-19 oral pill
- Blinded blended mortality rates encouraging compared to mortality rates from
large platform studies such as RECOVERY
- Four independent DSMB recommendations to continue the study based on
unblinded safety and futility reviews
- Opaganib is host-targeted and is therefore expected to be effective against
emerging viral variants
RedHill Biopharma Ltd. [https://www.redhillbio.com/RedHill/ ] (Nasdaq: RDHL)
("RedHill" or the "Company"), a specialty biopharmaceutical company, today
announced that it has completed enrollment and randomized the last patient in
the global Phase 2/3 study with opaganib (Yeliva(R), ABC294640)[1] in patients
hospitalized with severe COVID-19 pneumonia (NCT04467840) [
https://clinicaltrials.gov/ct2/show/NCT04467840?term=NCT04467840&draw=2&rank=1
]. A total of 475 patients were randomized, more than the planned 464.
The primary endpoint of the study is the proportion of patients breathing room
air without oxygen support by Day 14. The study captures additional important
outcome measures in the follow up period of up to 6 weeks, such as the time to
hospital discharge, improvement according to the World Health Organization
Ordinal Scale for Clinical Improvement and incidence of intubation and
mortality.
An evaluation of the blinded blended intubation and mortality rates to date is
encouraging as compared to reported rates of mortality from large platform
studies such as RECOVERY, and other studies in similar patient populations[2].
Furthermore, four independent DSMB recommendations to continue the study were
already provided following unblinded safety and futility reviews.
"Enrollment completion of this 475-patient global study of oral opaganib for
COVID-19 is a truly exciting milestone in the urgent search for an effective
pill to treat COVID-19, positioning opaganib as a leading novel, dual-action,
investigational COVID-19 oral treatment," said Mark L. Levitt, MD, Ph.D.,
Medical Director at RedHill. "Acting on the cause and effect of COVID-19
through a dual antiviral and anti-inflammatory effect, opaganib is
host-targeted and is therefore expected to be effective against emerging viral
variants. With waves of COVID-19 continuing to wash over many countries,
coupled with the specter of new variants, it is more critical than ever that
the world has access to an oral pill to treat COVID-19."
In addition to ongoing discussions with the FDA and other regulators, the
Company has also met with the EMA to talk about a European pathway. As with all
discussions with regulatory bodies, next steps will be guided by study results.
Discussions are also ongoing with potential partners who are interested in the
rights to opaganib in various countries.
About Opaganib (Yeliva(R), 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 and has demonstrated positive safety and efficacy signals in
preliminary top-line data from a 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[3].
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(R) for opioid-induced constipation in
adults[4], Talicia(R) for the treatment of Helicobacter pylori (H. pylori)
infection in adults[5], and Aemcolo(R) 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(R), 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(R)), 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(R); (v) the Company's
ability to successfully commercialize and promote Movantik(R), Talicia(R) and
Aemcolo(R); (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] 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-hear comparison study.
[3] 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.
[4] Full prescribing information for Movantik(R) (naloxegol) is available at:
www.Movantik.com.
[5] Full prescribing information for Talicia(R) (omeprazole magnesium,
amoxicillin and rifabutin) is available at: www.Talicia.com.
[6] Full prescribing information for Aemcolo(R) (rifamycin) is available at:
www.Aemcolo.com.
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SOURCE: RedHill Biopharma Ltd.
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