Symbiomix announced positive results from the second pivotal Phase 3 trial of SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV).
The Phase 3 study was a randomized, double-blind, placebo-controlled trial evaluating a single, oral dose of SYM-1219 vs. placebo in 189 women with infrequent or recurrent BV. Treatment with SYM-1219 achieved statistically and clinically significant results across all primary and secondary endpoints, which were consistent with data from the first pivotal Phase 3 trial. Detailed findings will be presented at an upcoming medical meeting.
Symbiomix also announced a successful pre-NDA meeting with the FDA to discuss requirements for a planned New Drug Application (NDA) filing for SYM-1219 in the 4th quarter of 2016.
SYM-1219 is a potent, next-generation 5-nitroimidazole antibiotic anticipated to be the first and only single-dose oral therapy approved for BV.
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