Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company focused on orphan neuromuscular diseases, has closed the recruitment for its confirmatory Phase IIb FJORD study with JP-1730 (fipamezole) in Parkinson's disease dyskinesia.
The double-blind, randomized, placebo-controlled dose-escalation study evaluates the safety and efficacy of three doses of fipamezole compared to placebo over a treatment period of 28 days. A total of 180 patients have now been recruited and, with the current lower-than-expected drop-out rate, the target of 120 evaluable patients in the database will be exceeded. Top-line results from the study are expected in the third quarter of 2009.
Chief executive Klaus Schollmeier said: "we believe that the FJORD study will demonstrate the drug's efficacy and provide critical information for the late-stage development of JP-1730/fipamezole in order to make it available as quickly as possible to the benefit of Parkinson's sufferers."
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