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. 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.
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