Symbiomix has completed patient enrollment in a phase III clinical study, the second pivotal trial of SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV). Earlier this year Symbiomix announced positive results from the first pivotal trial for SYM-1219. Symbiomix expects to finish the second pivotal trial by the end of 2015, which would enable an NDA filing with the FDA in mid-2016.
Symbiomix also announced that the FDA has granted Fast Track designation to SYM-1219. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that are intended to treat serious conditions. Symbiomix announced this year that the FDA had designated SYM-1219 as a Qualified Infectious Disease Product (QIDP) for the treatment of BV. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review. Further, if ultimately approved by the FDA, SYM-1219 would be eligible for a five-year extension of exclusivity in addition to new chemical entity (NCE) market exclusivity.
The phase III study is a multicenter, prospective, randomized, double-blind, placebo-controlled trial. The company enrolled 189 women diagnosed with BV to compare a single oral dose of SYM-1219 as a complete course of therapy to placebo. The study is being conducted at 22 sites across the U.S. The primary endpoint is Clinical Response at 21 to 30 days post treatment, which is the same primary endpoint used for the first pivotal trial.