RedHill Biopharma Announces Compassionate Use Treatment with Opaganib of first COVID-19 Patients in Switzerland
PR88619
TEL AVIV, Israel and RALEIGH, N.C., March 22, 2021 /PRNewswire=KYODO JBN/ --
RedHill Biopharma Ltd. [https://www.redhillbio.com/RedHill/ ] (Nasdaq: RDHL)
("RedHill" or the "Company"), a specialty biopharmaceutical company, today
announced that it has acted on a request to provide opaganib[1] treatment on an
outpatient basis under compassionate use exemption for several Swiss patients
suffering from COVID-19 pneumonia.
Acting rapidly to ensure emergency transport and supply of drug, treatment was
initiated with orally-administered opaganib within the past week. Opaganib is a
novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with
demonstrated dual anti-inflammatory and antiviral activity, targeting a human
cell component involved in viral replication and therefore expected to be
effective against emerging viral variants with mutations in the spike protein.
Gilead Raday, RedHill's Chief Operating Officer, said: "We continue to do all
we can to support patients, and their treating physician, who are in need of
treatment options for COVID-19. Having recently reported positive Phase 2 data
with opaganib in the U.S., our ongoing global 464-patient Phase 2/3 study with
opaganib for severe COVID-19 is now more than two thirds enrolled."
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 advancing in a total of eight countries and approximately 40 recruiting
sites.
RedHill recently announced positive top-line safety and efficacy data
[https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=1
78&FID=2432&PID=0&IID=19319 ] 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.
Preclinical data have demonstrated anti-inflammatory, antiviral and
anti-thrombotic activities of opaganib, with the potential to ameliorate
inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic
damage. 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. Opaganib also demonstrated reduced
blood clot length, weight and total thrombus score in a preclinical model of
Acquired Respiratory Distress Syndrome.
Additionally, preclinical in vivo studies[2] have demonstrated that opaganib
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.
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® for opioid-induced constipation in
adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori)
infection in adults[4], and Aemcolo® 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®, 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 risk 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® (naloxegol) is available at:
www.Movantik.com.
[4] Full prescribing information for Talicia® (omeprazole magnesium,
amoxicillin and rifabutin) is available at: www.Talicia.com.
[5] Full prescribing information for Aemcolo® (rifamycin) is available at:
www.Aemcolo.com.
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Source: RedHill Biopharma Ltd.
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