RedHill Biopharma Announces Last Patient Visit in Phase IIa Study with RHB-104 for Multiple Sclerosis
(Thomson Reuters ONE) -
* The Phase IIa proof-of-concept study evaluates the safety and potential
efficacy of fixed oral dose RHB-104 as an add-on therapy to interferon beta-
1a for relapsing-remitting multiple sclerosis (RRMS)
* Analysis of the study is ongoing, with top-line final results expected in
the fourth quarter of 2016
* Previously announced interim results after completion of the 24-week RHB-
104 treatment period of the study demonstrated positive safety and
efficacy signals and support further clinical development
* 2016 U.S. and worldwide sales of multiple sclerosis therapies are estimated
to exceed $12 billion and $18 billion, respectively
* RHB-104 is also being evaluated as a treatment for Crohn's disease with an
ongoing first Phase III clinical study (the MAP US study) with interim DSMB
analysis expected in the fourth quarter of 2016
TEL-AVIV, Israel, Aug. 01, 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 inflammatory
and gastrointestinal diseases and cancer, today announced that the last patient
has completed the final scheduled follow-up visit in the Phase IIa proof-of-
concept clinical study evaluating RHB-104 in patients treated for relapsing-
remitting multiple sclerosis (RRMS).
The open label Phase IIa study (the CEASE-MS study) enrolled eighteen patients
suffering from RRMS and was designed with a series of exploratory endpoints to
evaluate the safety and potential efficacy of fixed oral dose RHB-104 as an add-
on therapy to interferon beta-1a. Patients received treatment with RHB-104 for
24 weeks and were evaluated for an additional 24-week follow-up period during
which they were treated with interferon beta-1a without RHB-104 add-on.
The analysis of the study is currently ongoing and top-line final results are
expected to be announced in the fourth quarter of 2016, subject to completion of
review requirements and completion of the clinical study report (CSR).
RHB-104 is a proprietary and potentially groundbreaking antibiotic combination
therapy in oral capsule formulation, with potent intracellular, anti-
mycobacterial and anti-inflammatory properties. Multiple sclerosis (MS) is a
chronic inflammatory, demyelinating disease of the central nervous system (CNS)
with an unknown etiology, believed to be multifactorial. Thought to be
autoimmune, the MS inflammatory process is also consistent with persistent
infection. The 2016 U.S. and worldwide sales of MS therapies are estimated to
exceed $12 billion and $18 billion, respectively(1).
RedHill announced in March 2016 encouraging top-line interim results from the
single-arm, open-label CEASE-MS study. Top-line interim results, after
completion of the 24-week treatment period of the study, demonstrated positive
safety and efficacy signals and support further clinical development, based on
encouraging preliminary data.
As previously announced, the top-line interim results demonstrated an annualized
relapse rate (ARR) at 24 weeks of 0.288 in the modified intent-to-treat (mITT)
population and 0.0 in the per-protocol (PP) population, comparing favorably with
previously reported pivotal studies of interferon beta-1a therapies
Avonex(®) (0.67) (2) and Rebif(®) (0.87-0.91) (3).
88% of the mITT patient population and 100% of the PP patient population were
relapse free at 24 weeks, comparing favorably with previously reported pivotal
data on the use of Rebif(®) (75%) in comparison with Avonex(®) (63%) as
standalone first-line therapies(4). No patient in the CEASE-MS study relapsed
after week 8 of treatment.
Expanded Disability Status Scale (EDSS) scores, a standard measure of MS
disability, indicated the disease was stable during the treatment period and
there was a signal of improvement; No increase in total EDSS was observed in any
of the patients in the study.
With only a single active T1 post gadolinium lesion noted among all patients
followed, combined unique active lesions (CUAs) - the primary outcome measure in
the CEASE-MS study - were almost entirely MRI T2 lesions. Although not powered
for efficacy, a reduction in total MRI T2 lesion volume was observed at 24
weeks, as compared to baseline, suggesting a decreased burden of disease and
comparing favorably with previously reported Avonex(®5) and Rebif(®6) data. No
clinically significant change was observed for total CUA lesions at week 24,
which is supportive of a stable disease state.
RHB-104 was found to be safe and well tolerated, with no drug-related serious
adverse events or other clinically relevant or unexpected adverse events.
RHB-104 is a multifaceted drug that, in addition to bactericidal properties
against intracellular infections, has potentially distinct mechanisms of action
that include both anti-inflammation and neuroprotection. The Phase IIa CEASE-MS
study was initiated following several successful pre-clinical studies conducted
by RedHill with RHB-104.
RHB-104 is also currently undergoing a first Phase III study for Crohn's disease
in the U.S., Canada, Israel, Australia and Europe (the MAP US study). Interim
data and safety monitoring board (DSMB) analysis of the ongoing randomized,
double-blind, placebo-controlled MAP US study is expected in the fourth quarter
of 2016.
The MAP US Phase III study and the CEASE-MS Phase IIa study are registered
on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes
of Health, which provides access to information on publicly and privately
supported clinical studies.
About Multiple Sclerosis:
Multiple sclerosis (MS) is a chronic inflammatory, demyelinating disease of the
central nervous system with an unknown etiology, believed to be multifactorial.
A dysfunctional immune system in MS patients causes recurrent inflammatory
attacks on the central nervous system (CNS), leading to neurological disability.
Diffuse inflammatory and demyelinating lesions, also known as plaques, are the
main pathological finding in MS neural tissue. The lesions are primarily found
in the spinal cord, optic nerves, brainstem and periventricular white matter.
The symptoms of MS are dictated by the location of the lesions within the CNS.
Geographic variation in MS distribution, which cannot be solely explained by
population genetics, supports the notion that environmental factors also hold
etiological importance. There is currently no known cure for MS and available
treatments are mainly intended to manage or prevent relapses or reduce symptoms.
In 2015, there were estimated to be over 900,000 diagnosed patients with MS
worldwide. Approximately 85% of MS patients initially exhibit relapse-remitting
disease (RRMS). The 2016 U.S. and worldwide sales of MS therapies are estimated
to exceed $12 billion and $18 billion, respectively(7).
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 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.
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 inflammatory and gastrointestinal
diseases and cancer. RedHill's current pipeline of proprietary products
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 and an ongoing proof-of-concept
Phase IIa study for multiple sclerosis; (iii) BEKINDA((TM)) (RHB-102) - a once-
daily oral pill formulation of ondansetron with an ongoing Phase III study in
the U.S. 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 uPA inhibitor, administered by oral capsule,
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 Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and
other gastrointestinal cancers; (viii) RIZAPORT((TM)) (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.
(1) GlobalData PharmaPoint report, August 2015.
(2) Jacobs LD et al.: Ann Neurol 1996;39:285-294.
(3) PRISMS Study Group: Lancet 1998; 352: 1498-504.
(4) EVIDENCE Trial, Panitch H et al.: Neurology 2002;59:1496-1506.
(5) Cohen J A et al.: Oral Fingolimod or Intramuscular Interferon for Relapsing
Remitting Multiple Sclerosis. NEJM. 2010, 362: 402-15.
(6) Cohen J A et al.: Alemtuzumab versus Interferon Beta 1a as First-Line
Treatment for Patients with Relapsing-Remitting Multiple Sclerosis: a Randomised
Controlled Phase 3 Trial. The Lancet. 2012, 380: 1819-28.
(7) GlobalData PharmaPoint report, August 2015.
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 GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: RedHill Biopharma Ltd. via GlobeNewswire
[HUG#2032256]
Datum: 01.08.2016 - 14:07 Uhr
Sprache: Deutsch
News-ID 486542
Anzahl Zeichen: 16105
contact information:
Town:
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Kategorie:
Business News
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