Phase III study of SYM 1219 (secnidazole) met endpoints for bacterial vaginosis- Symbiomix

Symbiomix has announced positive results from the second pivotal trial of lead product candidate SYM 1219 (secnidazole) for the treatment of bacterial vaginosis (BV). The second pivotal trial of SYM 1219 for the treatment of BV was a Phase III, randomized, double-blind, placebo-controlled trial in 189 women comparing a single, oral dose of SYM-1219 to a placebo in both infrequent sufferers and patients with recurrent BV. SYM 1219 achieved statistically and clinically significant results across all primary and secondary endpoints.

These results were consistent with data from the first pivotal trial, which were presented at the 2015 Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting. The complete data from this Phase III study will be presented at an upcoming medical meeting.

The company also announced a successful pre-NDA meeting with the U.S. Food & Drug Administration (FDA) to discuss the requirements for a New Drug Application (NDA) filing for SYM 1219. These milestones keep the product on track for a planned NDA filing in the fourth quarter of 2016. SYM 1219 has been designated a Qualified Infectious Disease Product (QIDP) by the FDA, which makes the product eligible for priority review and at least 10 years of market exclusivity.

Comment:The antibiotic is sold as Flagentyl in countries like the Congo and Vietnam. It also has a close structural resemblance to metronidazole--sold as Flagyl to treat bacterial infections--which is one of the standard antibiotics used for bacterial vaginosis (BV).A single oral dose has been shown to be effective against BV in a high percentage of cases, making it a superior drug to metronidazole, which requires multiple dosing and therefore has only a relatively low adherence rate among patients.