Symbiomix today announced the completion of patient enrollment in a Phase 3 clinical study, the second pivotal trial of SYM-1219, which is 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 this second pivotal trial by the end of 2015, which would enable a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (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. Earlier this year Symbiomix announced 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.