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news.US-based biopharmaceutical firm Symbiomix Therapeutics has dosed first patient in a Phase III clinical trial, the second of two planned pivotal trials for its lead drug candidate, SYM-1219, to treat bacterial vaginosis (BV).
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Earlier, the company had announced 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 and this new Phase III trial is the second pivotal study to support an NDA submission for BV.
SYM-1219 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.
Symbiomix president and CFO Robert Jacks said: "With the start of this Phase 3 clinical trial we remain on track for an anticipated NDA filing of SYM-1219 for the treatment of BV in the U.S. in mid-2016.
"We anticipate rapid patient enrollment into this trial with plans to complete the study by the end of 2015."
The multi-center, prospective, randomized, double-blind, placebo-controlled Phase III trial is a very similar design to the previous pivotal Phase II trial and it will be conducted at more than 20 sites across the US.
The trial will enrol around 180 women diagnosed with BV to compare a single oral dose of SYM-1219 as a complete course of therapy to placebo.
The primary endpoint of this Phase III trial is Clinical Response at 21 to 30 days post treatment, which is the same endpoint used for the successful Phase II trial completed last year.
The company intends to file an NDA for SYM-1219 for the treatment of BV next year.