The Parkinson disease (PD) candidate safinamide can help hold off the development or worsening of dyskinesia in mid- to late-stage patients for two years, according to initial data from an 18-month extension to a previously completed Phase III safinamide trial.
Topline data from the 018 extension study has been reported by Newron Pharmaceuticals and its safinamide licensee Merck Serono. The results showed that patients with advanced PD who were given either 50 mg or 100 mg of safinamide in addition to their existing levodopa therapy for up to two years demonstrated albeit nonstatistically significant dose-dependent mean improvements in dyskinesia rating scale (DRS) of 0.19 and 0.28, respectively. This compared with an average DRS measurement deterioration of 0.32 for patients given placebo in addition to levodopa.
Study 018 was designed as an extension to the previously completed six-month 016 trial, and included 544 patients from the original 016 trial. Of these, 440 patients completed study 018, Newron and Merck Serono report. “These long-term treatment results are encouraging because they confirm the safety profile of safinamide and its effect on motor function observed in the six-month study in this advanced PD population,” comments Berhard Kirschbaum, Ph.D., head of global R&D and Merck Serono. “The effect of safinamide on dyskinesia will be further explored in an ongoing dedicated pilot study.”
The clinical development program for safinamide includes the completed studies 015, 016, and 017, as well as the ongoing Motion and Settle trials. The drug is in development both as an add-on therapy to dopamine agonists in patients with early PD, and as add-on therapy to levodopa in patients with advanced PD. Data from the original 016 study was reported in 2009. The results showed that for mid- to late-stage PD patients with motor fluctuations, adding safinamide to existing levodopa therapy increased their mean daily “ON” time by 1.3 hours.
Newron granted what is now Merck Serono exclusive worldwide rights to develop, manufacture, and commercialize safinamide for PD, Alzheimer disease, and other cognitive disorders back in 2006.