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news.Positive results of Symbiomix Therapeutics' first pivotal trial for lead drug candidate SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV), were presented today at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting in Portland, Oregon.
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The results from the multi-center, randomized Phase 2 trial showed that a single oral dose of SYM-1219 met the trial’s primary endpoint of Clinical Outcome Responder and was well tolerated for the treatment of BV.
Based on discussions with the U.S. Food and Drug Administration (FDA) at an End-of-Phase 2 meeting, the Company plans to submit the Phase 2 trial as one of two pivotal studies for a New Drug Application (NDA). A second pivotal trial of SYM-1219 is currently enrolling patients, with targeted completion by the end of 2015. If the second pivotal trial is successful, an NDA could be submitted in mid-2016.
SYM-1219 is a novel drug candidate that contains secnidazole, an antibiotic with favorable pharmacokinetics (PK) allowing for single-dose oral therapy to treat BV, a condition that is marked by high recurrence rates and low adherence to the current recommended treatments.
The pivotal study data presented today were from a multi-center, prospective, randomized, double-blind, placebo-controlled study in 215 women conducted at 24 clinical sites across the U.S. that 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 percent Clinical Outcome Responder rate at 21 to 30 days post treatment in the modified intent to treat (mITT) population, versus 17.7 percent for placebo, a statistically significant (pAmerican Journal of Obstetrics & Gynecology.
Symbiomix Chief Medical Officer Carol Braun, M.D. commented, "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 company is currently enrolling patients into a second pivotal trial of SYM-1219 for the treatment of BV. The second pivotal trial has a very similar design to the first pivotal trial, including the same primary endpoint.
"The excellent results from this pivotal Phase 2 study allow us to begin to think ahead to the commercialization of SYM-1219, as we are targeting a 2017 launch," said Robert Jacks, President and CFO of Symbiomix.
SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of BV. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review and fast-track designation.
Further, if ultimately approved by the FDA, SYM-1219 would be eligible for a five-year extension of exclusivity as an addition to new chemical entity (NCE) market exclusivity.