RedHill Biopharma Announces Presentation of Positive Oral Opaganib Phase 2 Data in COVID-19
PR90211
TEL AVIV, Israel and RALEIGH, NC, June 21, 2021, /PRNewswire=KYODO JBN/--
Positive U.S. Phase 2 safety and efficacy data for opaganib, a leading novel,
oral, dual-mechanism drug candidate for moderate-to-severe COVID-19, presented
at the World Microbe Forum
Opaganib was associated with a reduction in the need for supplemental oxygen
support, earlier time to discharge from hospital and was well tolerated
Opaganib's global 475-patient Phase 2/3 study is fully enrolled, with study
completion expected in the coming weeks
Opaganib is host-targeted and 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 presentation of the positive Phase 2 safety and efficacy data for
oral opaganib (Yeliva(R), 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]
[https://clinicaltrials.gov/ct2/show/NCT04414618 ]. 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(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, 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(R) for opioid-induced constipation in
adults[5], Talicia(R) for the treatment of Helicobacter pylori (H. pylori)
infection in adults[6], and Aemcolo(R) 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(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] 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(R) (naloxegol) is available at:
www.Movantik.com.
[6] Full prescribing information for Talicia(R) (omeprazole magnesium,
amoxicillin and rifabutin) is available at: www.Talicia.com.
[7] 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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