Santhera Wins FDA Grant for Muscular Dystrophy Trial
FDA’s Office of Orphan Products Development awarded Santhera Pharmaceuticals a $246,000 grant for its ongoing Phase I trial of omigapil to treat congenital muscular dystrophy.
Santhera is conducting the trial, CALLISTO, in collaboration with the NIH. In May 2016, omigapil received a fast track designation for omigapil for the treatment of CMD, and was previously granted orphan drug designations in the United States and the EU.
CALLISTO is evaluating the pharmacokinetics, safety and tolerability of omigapil in ambulatory and non-ambulatory children affected by either two subtypes of CMD, COL6-RD or LAMA2-RD. The study is expected to be completed in the first half of 2017.