Santhera's MICONOS Trial with Catena®/Sovrima® in Friedreich's Ataxia Misses Primary Endpoint
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Liestal, Switzerland, May 20, 2010 - Santhera Pharmaceuticals (SIX: SANN)
announced today that its MICONOS Phase III study evaluating Catena®/Sovrima® for
the treatment of Friedreich's Ataxia missed its primary endpoint. Trends towards
improvement in the key neurological endpoint were however identified by a
meta-analysis of all Santhera's Phase II and III studies in the same indication.
MICONOS also confirmed that Catena®/Sovrima® is safe and well tolerated at doses
of up to 2250 mg/day.
The 12-month MICONOS (Mitochondrial Protection with Idebenone In Cardiac Or
Neurological Outcome Study) study enrolled 232 primarily adult patients and
evaluated the safety and efficacy of three doses of Catena®/Sovrima® compared to
that of placebo. Analysis of the primary endpoint of the study, mean change in
the International Cooperative Ataxia Rating Scale (ICARS) score from baseline,
did not detect any significant difference between the active dose arms and
placebo. Secondary endpoints, including the proportion of patients improving on
ICARS score (responder analysis) and change in the Friedreich's Ataxia Rating
Scale also did not show statistically significant differences between the
placebo and active dose groups. Although a detailed analysis of cardiac
endpoints is still ongoing, there was no difference between the active and
placebo groups in the key cardio logical secondary endpoint assessing a
combination of anatomical and functional cardiac parameters.
A meta-analysis of Santhera's three Phase II and III studies including 344
patients of all age groups and disease stages showed trends for improvement on
Catena®/Sovrima® in the mean change in ICARS score in the combined mid- and high
dose groups compared to placebo (p=0.083) as well as in the high dose group
compared to placebo (p=0.088). Similarly, a larger proportion of patients
improved by at least 2.5 ICARS points over a six months treatment period in the
Catena®/Sovrima dose groups (placebo: 30.4%; mid-dose group 39.1%; high dose
group 41.9%) and comparison with placebo showed a trend in favor of the combined
mid and high dose groups (p=0.10) and the high dose group (p=0.098).
The pharmacokinetic analyses of study participants revealed detectable levels of
idebenone or its metabolites in the blood of 12% of the patients in the placebo
arm. With the exception of one, none of these individuals declared prior use of
idebenone before joining the MICONOS study.
Webcast/Teleconference
At 17:00 CET / 16:00 UKT / 11:00 EST on May 20, 2010, Santhera's management will
host a teleconference/webcast. You can either join the webcast on
www.santhera.com/webcast or the teleconference using the conference ID 76973094
and one of the following dial-ins:
Europe +44 (0) 1452 555 566
USA +1 866 966 9439
Canada +1 866 966 0399
The webcast will be available for playback one hour after the analyst
presentation ends.
Thomas Meier, Chief Scientific Officer, commented: "We are surprised and
disappointed by the MICONOS results. The outcome of the study represents a major
set-back for us and the whole Friedreich's Ataxia community. However, we now
have results from three clinical studies which, when combined, show a trend for
superiority of Catena®/Sovrima® compared to placebo as assessed by the ICARS.
Before deciding on how to proceed with the development program, we will analyze
the data from the two ongoing extension studies which will provide important
long-term follow-up data on the use of the drug in Friedreich's Ataxia patients.
Considering the data from all three clinical studies, we are convinced that
individual patients benefit from Catena®/Sovrima®, although we were not able to
demonstrate this conclusively in this clinical trial of still limited size and
duration. In this slowly and variably progressing neurological disorder, where
patients experience daily fluctuations in their disease status, it remains a
challenge to demonstrate changes in neurological functions in the short-term."
Klaus Schollmeier, Chief Executive Officer, commented: "The MICONOS results are
an unexpected setback for us. However, we have a broad late-stage pipeline which
includes three distinct molecules in seven indications and we have sufficient
cash reserves to fund it. We remain optimistic about the medical and commercial
potential of Catena®/Sovrima® and now wait for data from the long-term extension
studies in Friedreich's Ataxia, the RHODOS Phase II study in Leber's Hereditary
Optic Neuropathy which are due within the next few weeks as well as from the
MELTIMI Phase II study in MELAS syndrome. Interim data from the DELOS Phase III
study in Duchenne Muscular Dystrophy, which is based on a different mechanism of
action, are also expected in the second half of this year."
Santhera's late-stage pipeline includes Catena®/Sovrima® in four additional
indications, fipamezole in Dyskinesia in Parkinson's Disease currently prepared
for Phase III development in the United States of America by partner Biovail,
and omigapil in Congenital Muscular Dystrophy, which is in preparation for a
Phase II/III study. All development programs cover a high unmet medical need and
address substantial market opportunities in niche and orphan indications.
About the MICONOS study
The MICONOS study was a randomized, double blind, placebo controlled trial
testing the efficacy and safety of three doses of Catena®/Sovrima® and placebo
over a 12 months treatment period. The doses tested were 180/360 mg/day (low
dose for patients ? and >45 kg body weight), 450/900 mg/day (mid-dose) and
1350/2250 mg/day (high dose). Patients of all age groups and disease stages were
enrolled into the study, which was initiated in December 2005 and conducted in
13 study centers in Europe.
About Friedreich's Ataxia
Friedreich's Ataxia is a devastating inherited disease associated with
progressive neurodegeneration. The disorder is caused by mutations in the gene
that encodes for frataxin. Lack of this protein impairs the energy production in
the mitochondria, the energy production centers in each cell, and damages
nervous and cardiac tissue.
First symptoms typically develop from around 5 to 15 years of age. Coordination
difficulties such as unsteady gait, frequent falls or clumsiness usually appear
first. Gait ataxia then spreads to the arms and the trunk. Speech is almost
always affected, making communication increasingly difficult. Patients become
wheelchair-bound and require continuous care. Cardiomyopathy is a common
complication of Friedreich's Ataxia and while it may be asymptomatic early on,
it remains a leading cause of death.
* * *
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company
focused on the development and commercialization of innovative pharmaceutical
products for the treatment of severe neuromuscular diseases, an area of high
unmet medical need which includes many orphan indications with no current
therapy. Santhera's first product, Catena® to treat Friedreich's Ataxia, is
marketed in Canada. The drug is also being investigated in a Phase III study in
Duchenne Muscular Dystrophy for which commercial rights in Europe are licensed
to Takeda Pharmaceutical. Santhera's second compound fipamezole recently showed
efficacy in reducing levodopa-induced Dyskinesia in Parkinson's Disease.
Phase III development and commercialization rights in the United States and
Canada are partnered with Biovail. For further information, please visit the
Company's web site www.santhera.com
Catena® is a trademark of Santhera Pharmaceuticals.
For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone: +41 (0)61 906 89 52
klaus.schollmeier(at)santhera.com
Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54
barbara.heller(at)santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach(at)santhera.com
Disclaimer/Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for
or purchase any securities of Santhera Pharmaceuticals Holding AG. This
publication may contain certain forward-looking statements concerning the
Company and its business. Such statements involve certain risks, uncertainties
and other factors which could cause the actual results, financial condition,
performance or achievements of the Company to be materially different from those
expressed or implied by such statements. Readers should therefore not place
undue reliance on these statements, particularly not in connection with any
contract or investment decision. The Company disclaims any obligation to update
these forward-looking statements.
[HUG#1417424]
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Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Switzerland
ISIN: CH0027148649;
MICONOS_Results: http://hugin.info/137261/R/1417424/367879.pdf
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Datum: 20.05.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 21187
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