2013-03-21 08:09:56 -
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 21 March 2013 at 9.00 a.m.
Biotie Presents Tozadenant Phase 2b data at AAN Annual Meeting
Biotie announced today that full data from a Phase 2b study evaluating
tozadenant (SYN115) in Parkinson's disease (PD) patients experiencing levodopa
related end of dose wearing off were presented at the 65(th) Annual Meeting of
the American Academy of Neurology (AAN) in San Diego, March 20, 2013. These data
were selected by the AAN for the Emerging Science Program (formerly Late-
breaking Science Program) and were presented by Dr. C. Warren Olanow, Professor
of Neurology and Neuroscience at the Mount Sinai School of Medicine.
The study was an international, 12-week, double-blind, phase 2 trial in which
patients on stable dosages of levodopa with at least 2.5 hours
(hr) of OFF time
per day were randomized to tozadenant 60, 120, 180 or 240 mg BID, or matching
placebo. The primary outcome measure was the change from baseline to Week 12 in
hours per day spent in the OFF state. A mixed-model repeated-measures ANCOVA
was used for analyses with a pre-specified hierarchical step-down approach to
test multiple dose groups.
Of 420 patients randomized, 337 completed treatment. Their mean age was 63.3
years, mean duration of PD 8.7 years, and their mean OFF time at baseline was
about 6 hr/day. Significant reductions in mean placebo-corrected change from
baseline in OFF time were observed with tozadenant (modified Intention to Treat
population) 120 mg BID (-1.1 hr, p=0.0039) and 180 mg BID (-1.2 hr, p=0.0039).
The amount of time patients spent in the ON time with troublesome dyskinesia was
not significantly increased in any tozadenant group. Mean placebo-corrected
scores on the Unified Parkinson's Disease Rating Scale (UPDRS) part III
significantly improved with tozadenant 120 mg BID (-2.2, p=0.0325) and 180 mg
BID (-2.5, p=0.0325), and mean placebo-corrected UPDRS I-III scores improved
significantly in all tozadenant groups (all groups, p< 0.03) The changes were
also perceptible to both physicians and patients, as reflected in statistically
significant improvements on global ratings. Mean placebo-corrected scores on the
clinician-administered global impressions of severity (CGI-S) and improvement
(CGI-I) improved significantly in all tozadenant groups, and placebo-corrected
scores on patient ratings (Patient Global Impression; PGI) significantly
improved in the 120 mg BID group. The most common adverse events in the combined
tozadenant groups were dyskinesia, nausea, dizziness, constipation, PD
worsening, insomnia and falls.
Steve Bandak, Chief Medical Officer of Biotie stated, "We are very pleased that
these data were selected for inclusion in AAN's Emerging Science Program and
believe it reflects the scientific importance of these findings and the
potential opportunity for tozadenant as a new treatment for Parkinson's
disease". He continued, "We are now working closely with our partner UCB Pharma
for further development of tozadenant and plan to start the phase 3 program by
Turku, 21 March 2013
Biotie Therapies Corp.
President and CEO
For further information, please contact:
Dr. Stephen Bandak, Chief Medical Officer
tel. +1 650 296 0946 (Pacific Time zone), email: firstname.lastname@example.org
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: email@example.com
NASDAQ OMX Helsinki Ltd
Tozadenant is an orally administered, selective inhibitor of the adenosine 2a
(A2a) receptor being developed initially for the treatment of Parkinson's
disease. A2a receptors are expressed in high concentration in the striatum of
the brain and are thought to play an important role in regulating motor
function. Tozadenant blocks the effect of endogenous adenosine at the A2a
receptors, resulting in the potentiation of the effect of dopamine and
inhibition of the effect of glutamate at the mGluR5 receptor. Biotie has granted
UCB Pharma S.A. a license for exclusive, worldwide rights to tozadenant.
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's most advanced product, Selincro(TM) (nalmefene), licensed to Lundbeck
A/S, has on 28 February 2013 received European marketing authorization for the
reduction of alcohol consumption in adult patients with alcohol dependence who
have a high level of alcohol consumption. In addition, Biotie has a strategic
collaboration with UCB Pharma S.A. covering tozadenant which is transitioning
into Phase 3 development for Parkinson's disease.
Biotie shares are listed on NASDAQ OMX Helsinki Ltd.
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Source: Biotie Therapies Oyj via Thomson Reuters ONE