Merck Serono sets Ph III PD drug trial in MOTION

Switzerland-based Merck Serono, a division of Germany's Merck KGaA, and Italian partner Newron Pharmaceuticals have initiated a Phase III trial of the candidate Parkinson's disease treatment, safinamide. The firms have been co-developing the agent since Merck Serono licensed it last year (Marketletter November 27, 2006).

The study, known as MOTION, is designed to compare the efficacy and safety of two daily dosing regimens, either 50mg or 100mg, in combination with stable-dose dopamine agonist therapy with dopamine alone. The 24-week program, which will seek to enroll around 650 patients with early-stage disease, will measure the change in Unified Parkinson's Disease Rating Scale from baseline.

Data from a previous Phase III trial, which also examined 50mg and 100mg doses as an adjunct to dopamine, showed that, while the drug had not significantly extended time-to-intervention, it had brought about a statistically-significant reduction in symptoms on the UPDRS scale (Marketletter September 2). In addition, safinamide was shown to increase responder rates, defined as those who achieved a minimum 30% improvement over six months.