RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL)
(“RedHill” or the “Company”), a specialty biopharmaceutical company
primarily focused on late clinical-stage development and
commercialization of proprietary, orally-administered, small
molecule drugs for gastrointestinal and inflammatory diseases and
cancer, today announced a planned poster presentation relating to
the active metabolite of MESUPRON, WX-UK1, at the 2017
AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics
Conference, on Sunday, October 29, 2017, from 12:30 - 4:00 PM, at
the Pennsylvania Convention Center in Philadelphia, PA.
MESUPRON is a proprietary, first-in-class,
orally-administered protease inhibitor, with several potential
mechanisms of action to inhibit tumor invasion and metastasis.
MESUPRON presents a new, non-cytotoxic approach to cancer therapy
and potentially to additional inflammatory gastrointestinal
diseases, such as diarrhea-predominant irritable bowel syndrome
(IBS-D), pancreatitis and inflammatory bowel disease (IBD).
The poster1, entitled ‘New potential therapeutic
applications of WX-UK1 as a specific and potent inhibitor of human
trypsin-2 and human trypsin-3’, was authored by scientists from the
Department of Molecular Biology and Genetics of Aarhus University
in collaboration with RedHill Biopharma. The abstract presents data
from non-clinical studies, concluding that WX-UK1 is a potent and
rather specific inhibitor of human trypsin-2 and human trypsin-3,
suggesting new potential therapeutic applications of WX-UK1 in
oncology and inflammatory gastrointestinal diseases.
RedHill acquired the exclusive worldwide
development and commercialization rights to MESUPRON, excluding
China, Hong Kong, Taiwan and Macao, from Germany’s WILEX AG for all
indications. WILEX AG completed several clinical studies with
MESUPRON for different indications, including two Phase II
proof-of-concept studies, one for pancreatic cancer and one for
metastatic breast cancer.
RedHill has an ongoing research collaboration
agreement with the Department of Molecular Biology and Genetics of
Aarhus University in Denmark for the evaluation of MESUPRON. The
non-clinical studies with MESUPRON are intended to support the
clinical data from previous Phase I and Phase II studies, and may
allow RedHill to take a precision medicine approach going forward.
Further evaluation of MESUPRON, together with Aarhus University,
may allow for selection of appropriate subpopulations of patients
toward demonstrating the activity of MESUPRON in planned clinical
trials.
About MESUPRON:MESUPRON is a
proprietary, first-in-class, orally-administered potent protease
inhibitor of human trypsin-2 and human trypsin-3, targeting
pancreatic cancer and inflammatory gastrointestinal diseases.
Protease inhibitors have been shown to play key roles in tumor
invasion and the metastasis process. High levels of certain
proteases are associated with poor prognosis in various solid tumor
cancers, such as pancreatic, gastric, breast and prostate cancers.
MESUPRON presents a promising new non-cytotoxic approach to cancer
therapy with several potential mechanisms of action to inhibit both
tumor metastasis and growth. MESUPRON has undergone several Phase I
studies and two Phase II proof-of-concept studies. The first Phase
II study was in locally-advanced, unresectable pancreatic cancer
and the second study in metastatic breast cancer in combination
with first-line chemotherapeutic agents. RedHill received a Notice
of Allowance from the United States Patent and Trademark Office
(USPTO) for a new patent covering the use of MESUPRON and RedHill’s
Phase II-stage investigational compound, YELIVA®, in combination
with a known antibiotic, for hard-to-treat cancers.
About RedHill Biopharma
Ltd.:RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock
Exchange:RDHL) is a specialty biopharmaceutical company
headquartered in Israel, primarily focused on the development and
commercialization of late clinical-stage, proprietary,
orally-administered, small molecule drugs for the treatment of
gastrointestinal and inflammatory diseases and cancer. RedHill
promotes three gastrointestinal products in the U.S. -
Donnatal®, a prescription oral adjunctive drug
used in the treatment of IBS and acute enterocolitis,
EnteraGam®, a medical food intended for the
dietary management, under medical supervision, of chronic diarrhea
and loose stools, and Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg, a prescription
proton pump inhibitor indicated for adults for the treatment of
gastroesophageal reflux disease (GERD) and other gastrointestinal
conditions. RedHill’s clinical-stage pipeline includes: (i)
TALICIA™ (RHB-105)
- an oral combination therapy for the treatment of
Helicobacter pylori infection with successful results from a first
Phase III study and an ongoing confirmatory Phase III study; (ii)
RHB-104 - an oral combination
therapy for the treatment of Crohn's disease with an ongoing first
Phase III study, a completed proof-of-concept Phase IIa study for
multiple sclerosis, and a planned pivotal Phase III study for
nontuberculous mycobacteria (NTM) infections; (iii)
BEKINDA® (RHB-102)
- a once-daily oral pill formulation of
ondansetron with successful top-line results from a Phase III study
in acute gastroenteritis and gastritis and successful top-line
results from a Phase II study in IBS-D; (iv)
RHB-106 - an encapsulated bowel
preparation licensed to Salix Pharmaceuticals, Ltd.; (v)
YELIVA® (ABC294640) - a Phase
II-stage, orally-administered, first-in-class SK2 selective
inhibitor targeting multiple oncology, inflammatory and
gastrointestinal indications; (vi) MESUPRON - a
Phase II-stage first-in-class, orally-administered protease
inhibitor, targeting pancreatic cancer and inflammatory
gastrointestinal diseases and (vii) RIZAPORT® (RHB-103)
- an oral thin-film formulation of rizatriptan for acute
migraines, with a U.S. NDA currently under discussion with the FDA
and marketing authorization received in two EU member states under
the European Decentralized Procedure (DCP). More information about
the Company is available at: www.redhillbio.com.
1 The poster was authored by Emil Oldenburg,
Christine R. Schar, Eva L. Lange and Jan K Jensen, from the
Institute of Molecular Biology and Genetics, Aarhus University and
Danielle T Abramson, Reza Fathi, Eric M. Towler, Mark Levitt, and
Terry F. Plasse from RedHill Biopharma.
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, without limitation, 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; (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
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; (v) the Company’s ability to
successfully market Donnatal® and EnteraGam®, (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 its own
marketing and commercialization capabilities; (viii) the
interpretation of the properties and characteristics of the
Company’s therapeutic candidates and of 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 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; and (xii) estimates of the
Company’s expenses, future revenues capital requirements and the
Company’s needs for additional financing; (xiii) the Company's
Expanded Access Program, which allows patients with
life-threatening diseases potential access, subject to regulatory
and other approvals, to RedHill’s investigational new drugs that
have not yet received regulatory marketing approval, if a patient
suffers an adverse experience using such investigative drug,
potentially adversely affecting the clinical development program of
that investigational product or the Company generally; (xiv)
competitive 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 February 23, 2017.
All forward-looking statements included in this Press Release are
made only as of the date of this Press Release. We assume no
obligation to update any written or oral forward-looking statement
unless required by law.
Company
contact:Adi FrishSenior VP Business Development &
Licensing RedHill Biopharma+972-54-6543-112adi@redhillbio.com |
IR contact
(U.S.): Marcy NanusSenior Vice President The Trout
Group+1-646-378-2927Mnanus@troutgroup.com |
Redhill Biopharma (NASDAQ:RDHL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Redhill Biopharma (NASDAQ:RDHL)
Historical Stock Chart
From Apr 2023 to Apr 2024