Santhera completes FJORD enrollment

22 April 2009

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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