RedHill Biopharma's Phase 2/3 COVID-19 Study of Opaganib Passes Fourth DSMB Review with Unanimous Recommendation to Continue
PR88927
TEL AVIV, Israel and RALEIGH, N.C., April 9, 2021 /PRNewswire=KYODO JBN/ --
- Independent Data Safety Monitoring Board unanimously recommends continuation
of the global Phase 2/3 study of orally-administered opaganib in severe
COVID-19 pneumonia based on review of unblinded safety data from the first 255
treated patients
- The 464-patient global Phase 2/3 COVID-19 study is over 75% enrolled, with
completion of enrollment expected in the coming weeks
- Opaganib potentially minimizes likelihood of resistance due to viral
mutations by targeting a human cell component involved in viral replication
RedHill Biopharma Ltd. [ https://www.redhillbio.com/RedHill/ ](Nasdaq: RDHL)
("RedHill" or the "Company"), a specialty biopharmaceutical company, today
announced that the global Phase 2/3 study with orally-administered opaganib
(Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia
has received a unanimous recommendation to continue, following a fourth
independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's
recommendation is based on an analysis of unblinded safety data from the first
255 patients treated for 14 days, extending the total opaganib safety database
to approximately 380 patients.
Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: "With
approximately 380 patients in the opaganib safety database following this
positive fourth DSMB review, we are building a clear picture of the safety
profile of opaganib." Dr. Levitt continued: "Moreover, adding together the
positive Phase 2 data, the successful DSMB futility reviews and the outcomes
from compassionate use of opaganib, we look forward with optimism to the
reporting of top-line data from the Phase 2/3 study, which will provide the
clearest indication to date of opaganib's promise in treating COVID-19."
The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled
study of opaganib in patients with severe COVID-19 pneumonia requiring
hospitalization and treatment with supplemental oxygen (NCT04467840) [
https://clinicaltrials.gov/ct2/show/NCT04467840?term=NCT04467840&draw=2&rank=1
], is over 75% enrolled in approximately 40 recruiting sites.
RedHill recently announced positive top-line safety and efficacy data [
]from the non-powered U.S. Phase 2 study with opaganib in 40 patients with
COVID-19 pneumonia, in which opaganib demonstrated greater improvement in
reducing oxygen requirement by end of treatment on Day 14, on top of
standard-of-care. The Phase 2 data also showed no material safety differences
between the opaganib and placebo on top of standard-of-care treatment arms -
further adding to the growing safety database for opaganib.
To find out more about RedHill Biopharma's Expanded Access policy, please
visit: www.redhillbio.com/expandedaccess.
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
demonstrated dual anti-inflammatory and antiviral activity that targets a host
cell component of viral replication, potentially minimizing the likelihood of
viral resistance. Opaganib has also shown anticancer activity and has the
potential to target multiple oncology, viral, inflammatory, and
gastrointestinal indications.
Opaganib 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 is also
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 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 mitigate pulmonary fibrotic damage, 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[2].
Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and
completed multiple successful preclinical studies in oncology, inflammation,
GI, and radioprotection models, as well as a Phase 1 clinical study in cancer
patients with advanced solid tumors and an additional Phase 1 study in multiple
myeloma.
The development of opaganib has been supported by grants and contracts from
U.S. federal and state government agencies awarded to Apogee Biotechnology
Corp., including from the NCI, BARDA, the U.S. Department of Defense and the
FDA Office of Orphan Products Development.
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[3], Talicia(R) for the treatment of Helicobacter pylori (H. pylori)
infection in adults[4], and Aemcolo(R) 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 (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 risk of a delay in top-line data from the Phase
2/3 COVID-19 study, that such a study may not be successful, 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] 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.
[3] Full prescribing information for Movantik(R) (naloxegol) is available at:
www.Movantik.com.
[4] Full prescribing information for Talicia(R) (omeprazole magnesium,
amoxicillin and rifabutin) is available at: www.Talicia.com.
[5] 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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