Biotie: Tozadenantmeets primary and multiple secondary endpoints in phase 2b study in Parkinson's disease

14-Dec-2012 - Finland

Biotie 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.

"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."

https://www.bionity.com/en/news/140903/biotie-tozadenantmeets-primary-and-multiple-secondary-endpoints-in-phase-2b-study-in-parkinson-s-disease.html