Phase III trial in progress for SYM 1219 for bacterial vaginosis - Symbiomix Therapeutics

A Phase III, multi-center, prospective, randomized, double-blind, placebo-controlled study is to evaluate the effectiveness and safety of SYM 1219 from Symbiomix Therapeutics for the treatment of women and post-menarchal adolescent girls with bacterial vaginosis and is currently recruiting participants. Target enrollment is 180 patients.

Symbiomix Therapeutics announced the dosing of the first patient in the Phase III clinical trial, the second of two planned pivotal trials for its lead drug candidate SYM 1219 for the treatment of bacterial vaginosis (BV).

Symbiomix previously announced that it plans to submit the multi-center, randomized Phase II trial completed last year as one of two pivotal trials required for a New Drug Application (NDA) filing. This Phase III trial is the second pivotal study to support an NDA submission for BV. SYM 219 is a novel drug candidate that contains secnidazole, an antibiotic with favorable pharmacokinetics (PK) allowing for single-dose oral therapy in a condition that is marked by high recurrence rates and low adherence to the current recommended treatment.

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.