Merck Serono announces phase III safinamide results

Merck Serono has announced the 18-month safety and efficacy results of a phase III clinical study assessing the use of safinamide in Parkinson’s disease patients.

When data from both dosage groups – 50-100 mg and 150-200 mg – were pooled, the primary endpoint of the trial did not reach the level of statistical significance.

The firm reports that the addition of a daily 50-100 mg dose of safinamide to dopamine agonist therapy reduced the number of patients experiencing an intervention when measured by a post-hoc analysis per dose group.

Merck Serono speculates that the lack of statistical significance of the primary endpoint may have arisen as a result of the lack of response with the high dose group.

Professor Anthony Schapira, chairman of the University Department of Clinical Neuroscience, Royal Free and University College London Medical School, said: “These 18-month data suggest that, at a dose of 50 to 100 mg once daily, safinamide may delay the time to intervention for therapeutic adjustment and provide sustained improvement of Parkinson’s disease symptoms when added to dopamine agonist therapy.”

He added that further phase III clinical trials have been planned for continued investigation of this dose of safinamide, with approval of the compound potentially meeting an area of vital unmet medical need for the neurodegenerative condition.

In June 2006, Merck Serono and Newron Pharmaceuticals published data suggesting that administration of safinamide could have a beneficial effect on cognitive performance in Parkinson’s disease patients.