Symbiomix completes enrollment in second pivotal trial of SYM-1219 for bacterial vaginosis

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.

"The Symbiomix team has executed an aggressive timeline to drive SYM-1219 towards the market," said Robert Jacks, President and CFO. "Completing patient enrollment in this Phase 3 trial in less than four months, and achieving FDA Fast Track designation, are important milestones against our goal of filing an NDA by the middle of next year."

The Phase 3 study is a multi-center, 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.

Symbiomix Chief Medical Officer Carol Braun, M.D., said, "The ability to safely and effectively treat BV with a single oral dose of SYM-1219 would be an important clinical breakthrough for the millions of women in the United States suffering from this serious women’s health infection."

SYM-1219 is a novel drug candidate containing secnidazole, which is a next-generation, 5-nitroimidazole antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy. Symbiomix is executing a rapid clinical development program with the goal of bringing the drug to the U.S. market for several serious women’s health infections, including BV.