Symbiomix Therapeutics has presented the first pivotal trial results of it’s drug candidate SYM-1219 for the treatment of bacterial vaginosis (BV).
SYM-1219 is a single-dose and novel oral product that includes secnidazole, an antibiotic with favourable pharmacokinetics (PK) allowing for single-dose oral therapy to treat BV.
According to the firm, the trial results demonstrated that a single oral dose of SYM-1219 met the primary endpoint of clinical outcome responder (COR) and was well tolerated to treat BV.
Symbiomix Therapeutics chief medical officer Dr Carol Braun said: “Importantly, SYM-1219 achieved these clinical results with a single oral dose. These data suggest that treatment with SYM-1219 may lead to improved treatment outcomes for women with this serious disease.”
The multi-centre, prospective, randomised, double-blind and placebo-controlled study enrolled 215 women at 24 clinical sites across the US.
In the trial, the firm compared two different doses of SYM-1219 to placebo for the treatment of BV.
The results for the primary endpoint showed that a single oral dose of SYM-1219 containing 2g of secnidazole achieved a 67.7% COR rate at 21 to 30 days post treatment in the modified intent to treat (mITT) population against 17.7% for placebo, said the company.
Symbiomix president and CFO Robert Jacks said: “The excellent results from this pivotal Phase II study allow us to begin to think ahead to the commercialisation of SYM-1219, as we are targeting a 2017 launch.”
The company is currently enrolling patients for a second pivotal trial of SYM-1219, which is expected to complete by the end of this year.
Image: Bacterial vaginosis. Photo: courtesy of Per Grinsted / Medicinsk Webdesign.