Biotie's tozadenant (SYN115) meets primary and multiple secondary endpoints in phase 2b study in Parkinson's disease
ET | Source:Biotie Therapies
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 11 DECEMBER 2012 at 9:00
Biotie's tozadenant (SYN115) meets primary and multiple secondary endpoints in
phase 2b study in Parkinson's disease
Biotie today reported top-line data from a Phase 2b study evaluating its
adenosine A2a antagonist tozadenant (SYN115) in Parkinson's disease (PD)
patients experiencing levodopa related end of dose wearing off. The study met
its primary endpoint of a statistically highly significant decrease in 'off'
time vs. placebo, as well as demonstrating efficacy across multiple secondary
endpoints. Full data from the study will be disclosed at upcoming medical
conferences and in scientific publications.
In the 420 patient study, tozadenant displayed clinically relevant and
statistically highly significant effects on PD across multiple pre-specified
evaluation metrics including: a decrease vs. placebo in 'off' time, an increase
in 'on' time, an improved score on UPDRS part III and UPDRS parts I-III
combined, as well as improvements on clinician- and patient-assessed global
impression scores. Additionally, the study identified the minimally efficacious
and maximum feasible dose levels, as well as clinically useful target doses for
Phase 3. Tozadenant was generally well tolerated in the study. "This trial met
all the objectives to be expected of a Phase 2 study", said Dr. Stephen Bandak,
CMO of Biotie Therapies Corp.
Dr. C Warren Olanow, Professor of Neurology and Neuroscience at the Mount Sinai
School of Medicine stated "This important study demonstrated that the A2a
antagonist tozadenant reduced 'off' time in advanced PD patients. This agent,
which does not act directly on the dopamine system, represents a new class of
therapeutic agent that could be used to aid in the management of patients with
this potentially disabling disorder."
Dr. Robert Hauser, Professor of Neurology, Molecular Pharmacology and Physiology
at the University of South Florida stated "The patient reported outcomes
indicate that the overall effect of tozadenant was clinically relevant and
provided a meaningful improvement for patients. These results suggest that
tozadenant promises to be a useful treatment for Parkinson's disease patients
experiencing wearing off fluctuations on levodopa."
Dr. Karl Kieburtz, Professor of Neurology, Environmental Medicine, and Community
& Preventive Medicine at the University of Rochester added, "To see such
consistent, dose-responsive results in a Phase 2 study, with both patient-
reported and physician-based scales showing meaningful beneficial effects, is
both striking and gratifying."
"We are extremely pleased with the results of this study", said Timo Veromaa,
President and CEO of Biotie Therapies Corp. "The rigor with which the study was
conducted also makes us optimistic that it may be considered a pivotal study
within the envisioned development program. We look forward to analyzing the
results in detail with our license partner UCB and expect a decision from UCB in
the first quarter of 2013 regarding the next steps."
Turku, 11 December, 2012
Biotie Therapies Corp.
President and CEO
For further information, please contact:
Dr. Stephen Bandak, Chief Medical Officer
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About the study (ClinicalTrials.gov identifier: NCT01283594)
The completed Phase 2b study was a randomized, placebo-controlled, double-blind
dose-finding study conducted in the US, Canada, Chile, Argentina, Ukraine and
Romania. Altogether 420 PD patients experiencing levodopa related end of dose
wearing off were enrolled into the study. In these patients, treatment with
levodopa is insufficient to control PD symptoms until their next dose, resulting
in an 'off' period when symptoms reappear.
The subjects were randomized in an even ratio to receive either one of four dose
levels of tozadenant or matching placebo for 12 weeks, in addition to their
standard anti-PD medications. The primary goal of the study was to determine the
efficacy of tozadenant in reducing the mean number of hours per day spent in the
'off' state. The trial also assessed the safety of tozadenant and its impact on
various measures of motor symptom severity, dyskinesia and non-motor symptoms.
About tozadenant (SYN115)
Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist,
which enters the brain and modulates regions associated with motor and non-motor
function. Biotie holds a license from Roche for development and
commercialization of tozadenant in all indications.
Biotie has granted UCB Pharma S.A. a license for exclusive, worldwide rights to
tozadenant. Pending evaluation of the results of the now completed Phase 2b
study, UCB will be responsible for conducting the Phase 3 program and
commercializing tozadenant. UCB is expected to take a decision about this in the
first quarter of 2013.
About Parkinson's disease
Parkinson's disease is the second most common neurodegenerative disorder, after
Alzheimer's disease. It affects about one percent of people ages 65-69, rising
to up to three percent of people who are 80 years and older. The symptoms of
Parkinson's disease result from decreased dopamine production in regions of the
brain controlling movement.
Biotie is a specialized drug development company focused on the development of
drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease,
Alzheimer's disease and other cognitive disorders, alcohol and drug dependence
(addiction) and post-traumatic stress disorder), and inflammatory and fibrotic
liver disease. The company has a strong and balanced development portfolio with
several innovative small molecule and biological drug candidates at different
stages of clinical development. Biotie's products address diseases with high
unmet medical need and significant market potential.
Biotie has a strategic collaboration with UCB Pharma S.A. covering tozadenant
for Parkinson's disease. The Marketing Authorization Application for Biotie's
most advanced product, SelincroTM (nalmefene) for alcohol dependence was filed
in the EU by our partner H. Lundbeck A/S and was accepted for review by the
European Medicines Agency in December 2011. Biotie shares are listed on NASDAQ
OMX Helsinki Ltd.
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