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news.Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its partner Newron Pharmaceuticals have reported that the first Phase III trial of investigational agent safinamide as adjunctive therapy to levodopa met its primary endpoint by increasing daily 'ON' time in mid- to late-stage Parkinson's disease patients with motor fluctuations by 1.3 hours.
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‘ON’ time represents periods when Parkinson’s patients experience their best level of motor functioning.
According to the company, the two safinamide treatment groups of the study (receiving either safinamide 50mg orally once daily or safinamide 100mg orally once daily as adjunctive therapy to levodopa) demonstrated a statistically significant increase of daily total ‘ON’ time compared to placebo. Throughout the six months of the study, patients treated with both doses of safinamide experienced an average increase of ‘ON’ time of 1.3 hours per day compared to baseline.
Patients in the placebo group (receiving placebo in addition to levodopa and other anti-Parkinson therapies) reported an average increase of daily ‘ON’ time of 0.7 hour compared to baseline. The differences between both safinamide dose groups and placebo were statistically significant with p-values of 0.008 (safinamide 50mg daily) and 0.005 (safinamide 100mg daily).
This Phase III study was a six-month (24-week), randomized, double-blind, placebo-controlled international trial. It enrolled 669 patients with mid- to late-stage idiopathic Parkinson’s disease (more than three years of disease duration) receiving stable doses of levodopa, who had motor fluctuations with >1.5 hours of ‘OFF’ time during the day. The primary efficacy endpoint of the study was the increase in mean daily ‘ON’ time (‘ON’time without dyskinesia plus ‘ON’ time with minor dyskinesia) during an 18-hour period as assessed by patients’ recordings on diary cards.
Out of the 669 randomized patients, 89% of patients treated with safinamide completed the study (91% in the 50mg dose group and 87% in the 100mg dose group) compared to 89% in the placebo group. Over 90% of patients who completed the initial 24 weeks of treatment elected to enter a 78-week, placebo-controlled, double-blind extension study, which is ongoing, to specifically assess the effect on dyskinesias as primary endpoint.
Bernhard Kirschbaum, Merck Serono’s executive vice president for global R&D, said: The results indicate that safinamide, when used adjunctively to existing dopaminergic therapies for study patients in mid-to-late stages of Parkinson’s disease, increases daily ‘ON’ time of motor functioning. These results represent a further step toward our goal to provide patients and doctors with urgently needed new treatment possibilities in the neurodegenerative diseases therapeutic area.