Symbiomix reports positive results for SYM-1219 in bacterial vaginosis

SYM-1219 is a potent, next-generation 5-nitroimidazole antibiotic intended for single-dose oral treatment of BV.

Symbiomix also announced a successful meeting with the US Food & Drug Administration (FDA) to discuss the requirements for a new drug application filing for secnidazole in the fourth quarter of this year.

The phase 3 study was a randomized, double-blind, placebo-controlled trial evaluating a single, oral dose of SYM-1219 versus placebo in 189 women with infrequent or recurrent BV.

The company said SYM-1219 achieved statistically and clinically significant results across all primary and secondary endpoints. If approved, secnidazole would be the first single-dose oral therapy for BV.

Symbiomix head of R&D and chief medical officer Tom Beck said: "SYM-1219 is a true innovation for this common gynecological infection that can have serious health consequences.

"We believe that this single-dose oral treatment will be the best option for women suffering with BV."

SYM-1219 has superior pharmacokinetic properties that allow efficacy with significantly less total drug exposure than first generation nitroimidazoles, resulting in safety, tolerability and adherence.

The US FDA designated SYM-1219 a qualified infectious disease product, making the product eligible for priority review and at least 10 years of market exclusivity.

BV is the most common gynecological infection in the US among women ages 15 to 44. At present, over four million women are treated in the US for BV per year.