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Symbiomix Therapeutics declare positive Phase 3 Trial result of SYM-1219 & Pre NDA meeting with FDA

 

Clinical courses

Symbiomix announced positive results from the second pivotal trial of lead product candidate SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV). SYM-1219 (secnidazole) is a potent, next-generation 5-nitroimidazole antibiotic with superior pharmacokinetic properties that enable efficacy with significantly less total drug exposure than first generation nitroimidazoles, leading to excellent safety, tolerability and adherence.

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.

The second pivotal trial of SYM-1219 for the treatment of BV was a Phase 3, 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 3 study will be presented at an upcoming medical meeting.

“SYM-1219 is a true innovation for this common gynecological infection that can have serious health consequences,” commented Symbiomix Head of R&D and Chief Medical Officer Tom Beck, M.D. “We believe that this single-dose oral treatment will be the best option for women suffering with BV.”

“These milestones support our plan to file the SYM-1219 NDA in the fourth quarter of 2016,” said Robert Jacks, Symbiomix President and CFO. “We remain focused on commercial launch in 2017.”

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