RedHill Biopharma to Present at the 2017 MAP Conference
March 22 2017 - 7:00AM
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL)
(“RedHill” or the “Company”), a specialty biopharmaceutical company
primarily focused on the development and commercialization of late
clinical-stage, proprietary, orally-administered, small molecule
drugs for gastrointestinal and inflammatory diseases and cancer,
today announced that Ira Kalfus, MD, Medical Director at RedHill,
will present RedHill’s RHB-104 Phase III development program for
Crohn’s disease at the MAP (Mycobacterium avium subspecies
paratuberculosis) Conference, on Saturday, March 25, 2017, at 9:00
am EDT, at Temple University, Philadelphia, PA.
RHB-104 is a Phase III-stage proprietary,
orally-administered, potentially groundbreaking antibiotic
combination therapy with potent intracellular, antimycobacterial
and anti-inflammatory properties.
The development of RHB-104 is based on
increasing evidence supporting the hypothesis that Crohn’s disease,
and potentially other autoimmune diseases, are related to
Mycobacterium avium subspecies paratuberculosis (MAP) infection in
susceptible patients. The development of RHB-104 is consistent with
the growing awareness of the possibility that a bacterially-induced
dysregulated immune system may contribute to the pathogenesis of
various autoimmune diseases of unknown etiology.
RedHill is currently conducting a first Phase
III study with RHB-104 for the treatment of Crohn’s disease (the
MAP US study) in up to 150 clinical sites in the U.S, Canada,
Europe, Israel, Australia and New Zealand. The randomized,
double-blind, placebo-controlled Phase III study is intended to
evaluate the safety and efficacy of RHB-104 in patients with
moderately to severely-active Crohn’s disease. A second independent
Data and Safety Monitoring Board (DSMB) meeting of the MAP US
study, expected in mid-2017, will include an interim efficacy
analysis and will evaluate the option for an early stop for success
for overwhelming efficacy according to a pre-specified statistical
significance threshold.
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 has
a U.S. co-promotion agreement with Concordia for
Donnatal®, a prescription oral adjunctive drug
used in the treatment of IBS and acute enterocolitis. RedHill’s
clinical-stage pipeline includes: (i) RHB-105
- an oral combination therapy for the treatment of
Helicobacter pylori infection with successful results from a first
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 QIDP status for
nontuberculous mycobacteria (NTM) infections; (iii)
BEKINDA® (RHB-102)
- a once-daily oral pill formulation of
ondansetron with an ongoing Phase III study for acute
gastroenteritis and gastritis and an ongoing Phase II study for
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 other solid tumors 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 Germany in October 2015. More information about the
Company is available at: www.redhillbio.com.
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®, (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) 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 Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com
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