Synthetic Biologics slides on RRMS data

Synthetic Biologics Inc. (NYSE-M:SYN) said once-daily Trimesta plus Copaxone glatiramer acetate led to a non-significant 32% reduction in annualized relapse rate (ARR) at two years, the primary endpoint, vs. placebo plus Copaxone in a Phase II trial to treat relapsing-remitting multiple sclerosis (RRMS) in women (p=0.1527). The company said the 158-patient trial of the oral estriol was exploratory and therefore not powered to reach a p-value of <0.05 on the endpoint. Trimesta plus Copaxone led to a significant 47% reduction in ARR at 12 months vs. placebo plus Copaxone (p=0.0306). Data were presented at the American Academy of Neurology meeting in Philadelphia. The double-blind, U.S. trial was sponsored by the University of California, Los Angeles. Synthetic Biologics said it is determining next steps for Trimesta, including a potential Phase III program.

The data were released just before market close on Tuesday, sending Synthetic Biologics down $0.81 (28%) to $2.10. On Wednesday, the company slid a further $0.65 (31%) to $1.45. ...