Newron's safinamide misses Ph III efficacy endpoint

Newron Pharmaceuticals SpA, an Italian drug R&D company focused on novel central nervous system and pain therapies, and its partner Merck Serono, have reported positive preliminary results from a 12-month extension study of a Phase III trial of safinamide as an add-on treatment to dopamine agonist therapy in patients with early-stage Parkinson's disease.

Although the agent failed to achieve significance on its primary efficacy endpoint of time-to-intervention, results from the initial six-month trial, which were presented in May at the annual meeting of the American Academy of Neurology, suggest that, at a dose of 50mg to 100mg once-daily, safinamide may delay the time-to-intervention for therapeutic adjustment and provide sustained improvement of PD symptoms when added to dopamine agonist therapy, said Anthony Schapira, an investigator of the study. "Additional Phase III studies are planned to further assess the efficacy of this dose of safinamide. Because Parkinson's disease is a neurodegenerative disease, if approved, safinamide could meet an important unmet medical need," he added.

The Phase III, randomized, double-blind, placebo-controlled, international trial analysis of the primary efficacy measure indicated that safinamide treatment (data from all doses pooled) delayed the onset of the above events by 93 days (three months) as measured by the median time-to-event. However, the improvement from 559 days versus 466 days was not statistically significant (p=0.334).