SMT C1100: Phase Ib started

Summit began an open-label, dose-escalation, U.K. Phase Ib trial to evaluate 3 doses of oral SMT C1100 daily for 10 days in 12 DMD patients ages 5-11 years. The trial will use a nanoparticle aqueous suspension reformulation of SMT C11000 that the company previously used in a Phase I trial.

Last year, Summit reported data from a Phase I trial showing that all doses of the aqueous formulation of SMT C1100 were well tolerated and met the primary safety endpoint. Summit also said that the aqueous formulation improved absorption levels of the compound that were "above those anticipated to be needed to achieve clinical efficacy" (see BioCentury, Oct. 15, 2012). SMT C1100 has Orphan Drug designation in the U.S. and EU to treat DMD. ...