DGAP-News: RedHill Biopharma Ltd. / Key word(s): Study
RedHill Biopharma Ltd.: RedHill Biopharma Announces Last Patient Visit in
Phase IIa Study with RHB-104 for Multiple Sclerosis
03.08.2016 / 09:30
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Press Release
RedHill Biopharma Announces Last Patient Visit in
Phase IIa Study with RHB-104 for Multiple Sclerosis
- 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, August 3, 2016 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, 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(R) (0.67)[2] and Rebif(R) (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(R) (75%) in comparison with Avonex(R)
(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(R)[5] and Rebif(R)[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/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(R) - 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.
<pre>
Company contact: IR contact (U.S.):
Adi Frish Marcy Nanus
Senior VP Business Development & Senior Vice President
Licensing The Trout Group
RedHill Biopharma +1-646-378-2927
+972-54-6543-112 Mnanus@troutgroup.com
adi@redhillbio.com
</pre>
[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.
---------------------------------------------------------------------------
03.08.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
---------------------------------------------------------------------------
488809 03.08.2016
DGAP-News: RedHill Biopharma Ltd.: RedHill Biopharma Announces Last Patient Visit in Phase IIa Study with RHB-104 for Multiple Sclerosis
| Source: EQS Group AG