Santhera's congenital muscular dystrophy candidate well tolerated in Phase I

Santhera Pharmaceuticals Holding AG (SIX:SANN) reported data from the Phase I CALLISTO trial in 20 ambulatory and non-ambulatory patients ages 5-16 with congenital muscular dystrophy showing that once-daily 0.02-0.08 mg/kg doses of oral omigapil (SNT-317, TCH-346) for three months were well tolerated. The company also said the candidate achieved a pharmacokinetic profile "suitable for further development in pediatric patients." Santhera plans to discuss the data from the open-label, U.S. study with regulatory authorities to determine next steps for advancing omigapil to a pivotal trial...