Merck Serono and its Italian partner Newron Pharmaceuticals have presented promising late-stage data which suggest that their novel agent safinamide has an effect on cognitive performance in patients with early Parkinson’s disease.
The data, presented at the Movement Disorder Society’s 11th International Congress in Istanbul, Turkey, comes from a six-month, randomised, double-blind, placebo-controlled, international Phase III trial which showed that safinamide significantly improved motor symptoms and activities of daily living for patients in the trial, as an add-on treatment to dopamine agonist therapy.
The data demonstrated that the addition of safinamide to a stable dose of a single dopamine agonist resulted in an improvement in cognitive domains often impaired in Parkinson’s patients, in particular executive function, that is the ability for planning, organising, strategising and paying attention
to and remembering details, plus working memory.
From baseline to the 24th week, cognitive data were available for 41 patients randomised to safinamide 50mg-100 mg once daily, 38 to safinamide 150mg-200 mg once daily and 44 to placebo. Cognitive effects were seen as early as 12 weeks after starting safinamide treatment, but Merck Serono noted that the higher dose range did not offer any incremental advantage over safinamide 50mg-100mg.
Merck Serono signed a development and commercialisation deal with Newron last October for safinamide, which is also being investigated as a treatment for Alzheimer’s disease, restless leg syndrome and other cognitive disorders.