RedHill Biopharma to Host Webcast Today at 8:30 am EDT Following Announcement of Progress Update on RHB-104 Phase III Crohn's Disease Program Including the Introduction of an Option for Early Stop ...
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RedHill Biopharma to Host Webcast Today at 8:30 am EDT Following Announcement of
Progress Update on RHB-104 Phase III Crohn's Disease Program Including the
Introduction of an Option for Early Stop for Success in Q2/2017
TEL-AVIV, Israel, Oct. 06, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical
company primarily focused on development and commercialization of late clinical-
stage, proprietary, orally-administered, small molecule drugs for
gastrointestinal and inflammatory diseases and cancer, today announced that it
will host an interactive webcast and conference calltoday, Thursday October
6th, 2016, at 8:30 a.m. EDT, to discuss the progress update on the RHB-104 Phase
III Crohn's disease program.
Earlier today, the Company provided an update on its RHB-104 Phase III Crohn's
disease development program including the introduction of an option for early
stop for success for overwhelming efficacy in the second quarter of 2017,
planned enhancements to the first Phase III study with RHB-104 (the MAP US
study) and expected milestones and timelines.
Ira Kalfus, MD, Medical Director at RedHill Biopharma, noted: "The increased
number of patients and new open-label program reflect the strong and growing
interest we have had from our current investigators who see the potential
benefit of RHB-104 and the value of participating in this important study." Dr.
Kalfus further stated: "We do not expect these changes to significantly impact
timelines and the addition of an interim analysis for early stop for success,
expected in the second quarter of 2017, may in fact substantially shorten time
to study completion."
RHB-104 is a proprietary and potentially groundbreaking antibiotic combination
therapy in oral capsule formulation, with potent intracellular, anti-
mycobacterial and anti-inflammatory properties. RedHill is developing RHB-104
for the treatment of Crohn's disease, with the ongoing MAP US Phase III study
and for multiple sclerosis, with a Phase IIa study pending final results (the
CEASE-MS study).
The interactive webcast and conference call will be held today, Thursday,
October 6th, 2016 at 8:30 a.m. EDT. Participants who wish to ask questions
during the event can do so by telephone.
The live interactive webcast of the event, including slide presentation,
followed by a question-and-answer session, will be available through the
Company's website at: http://ir.redhillbio.com/events.cfm. Please access the
Company's website at least 15 minutes ahead of the conference to register,
download and install any necessary audio software.
Audio-only access to the webcast and an option of asking questions during the
event will also be available by telephone using the following dial-in
information: United States: +1-877-280-1254; Israel: +972-3-763-0146;
International: +1-646-254-3360. The access code for the call is: 8723708. The
webcast and accompanying presentation materials will be archived and available
for replay on the Company's website for 30 days.
About RHB-104:
Currently in a first Phase III study for the treatment of Crohn's disease (the
MAP US study), RHB-104 is a proprietary and potentially groundbreaking oral
antibiotic combination therapy, with potent intracellular, anti-mycobacterial
and anti-inflammatory properties. RHB-104 is based on increasing evidence
supporting the hypothesis that Crohn's disease is caused by Mycobacterium avium
subspecies paratuberculosis (MAP) infection in susceptible patients. Clinical
trials conducted with earlier formulations of RHB-104 include an Australian
Phase III study conducted by Pharmacia/Pfizer. RedHill has conducted several
supportive studies with the current formulation of RHB-104 and a long-term
population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III
MAP US study. RHB-104 is covered by several issued and pending patents. RedHill
is also conducting the CEASE-MS Phase IIa, proof-of-concept clinical study,
evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients
treated for relapsing-remitting multiple sclerosis (RRMS), with top-line interim
results announced and top-line final results expected in the fourth quarter of
2016.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a 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's current pipeline of proprietary products
includes: (i) RHB-105 - an oral combination therapy for the treatment
ofHelicobacter 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 and an ongoing proof-of-concept
Phase IIa study for multiple sclerosis; (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(TM) (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 uPA inhibitor, targeting gastrointestinal and other solid
tumors; (vii) RP101 - currently subject to an option-to-acquire by RedHill,
RP101 is a Phase II-stage first-in-class, orally-administered Hsp27 inhibitor,
targeting pancreatic and other gastrointestinal cancers; (viii) 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; and (ix) RHB-101 - a once-daily oral pill
formulation of the cardio drug carvedilol.
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 establish and
maintain corporate collaborations; (vi) 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; (vii) 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; (viii) the
implementation of the Company's business model, strategic plans for its business
and therapeutic candidates; (ix) 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; (x) parties from whom the Company
licenses its intellectual property defaulting in their obligations to the
Company; (xi) estimates of the Company's expenses, future revenues capital
requirements and the Company's needs for additional financing; (xii) competitive
companies and technologies within the Company's industry; and (xiii) the impact
of the political and security situation in Israel on the Company's business.
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 25, 2016.
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(at)redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus(at)troutgroup.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: RedHill Biopharma Ltd. via GlobeNewswire
Datum: 06.10.2016 - 13:05 Uhr
Sprache: Deutsch
News-ID 499223
Anzahl Zeichen: 11510
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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"RedHill Biopharma to Host Webcast Today at 8:30 am EDT Following Announcement of Progress Update on RHB-104 Phase III Crohn's Disease Program Including the Introduction of an Option for Early Stop ..."
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