Trial failure for Merck Serono’s Parkinson’s candidate
pharmafile | November 8, 2010 | News story | Research and Development | Merck Serono, Newron Pharmaceuticals, Parkinson's disease, dopamine agonists, levodopa, safinamide
Merck Serono’s new alpha-aminoamide safinamide has failed to reach its primary endpoint in a study with Parkinson’s disease patients.
Merck is developing the treatment with Newron Pharmaceuticals as add-on therapy to dopamine agonists or levodopa, the current gold standard therapy for Parkinson’s.
But the drug failed to make statistically significant changes to patients’ dyskinesia – the involuntary and twisting movements of the face and body which are a major complication of levodopa therapy.
The objective of the 18-month, double-blind, placebo-controlled extension study was to assess the long-term efficacy and safety of two doses of safinamide 50mg and 100mg once daily tablets following an earlier six-month phase III trial.
But after 24 months, improvements of just 0.19 and 0.28 in the Dyskinesia Rating Scale were observed in patients who received safinamide – versus a worsening of 0.32 for the placebo group.
Merck is putting a brave face on things, however. “These long-term treatment results are encouraging because they confirm the safety profile of safinamide,” says Bernhard Kirschbaum, head of global R&D at Merck Serono.
“The effect of safinamide on dyskinesia will be further explored in an ongoing dedicated pilot study,” he adds.
Merck says results of the exploratory analysis of the pre-specified main secondary endpoint were consistent with the effect on motor function observed in the first study.
“These results may offer new hope to patients with Parkinson’s disease as they need to take medications for long periods of time,” Newron chief executive Luca Benatti.
If it can prove itself, safinamide will share the Parkinson’s market with treatments such as Lundbeck’s Azilect and Boehringer Ingelheim’s Mirapexin/Sifrol.
In the UK, one person in 200 will contract Parkinson’s during their lifetime with the risk increasing with age (one in every 100 persons over 60 has Parkinson’s).
More common in men than in women, Parkinson’s is a brain disorder that causes muscle tremor, stiffness, and weakness, and in about a third of cases leads to dementia.
Adam Hill
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