Symbiomix Therapeutics today announced multiple milestones, including the closing of the third and final tranche of a $41 million Series A financing and positive results from a multi-center, randomized Phase 2 trial testing a single oral dose of SYM-1219 for the treatment of bacterial vaginosis (BV). Based on discussions with the U.S. Food and Drug Administration (FDA) at an End-of-Phase 2 meeting, the Company now is planning to submit the Phase 2 trial as one of two pivotal studies for a New Drug Application (NDA) filing in 2016. Simultaneously, the Company announced that the FDA recently designated SYM-1219 as a Qualified Infectious Disease Product (QIDP). SYM-1219 is a novel drug candidate that contains secnidazole, an antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy.
Investors participating in the financing included OrbiMed, Fidelity BioSciences, and HBM Partners, as well as financial services partner Square 1 Bank. The funds will be used to advance SYM-1219 through Phase 3 and towards the filing of an NDA.
"The Symbiomix team has made great progress in a short amount of time to advance our lead drug candidate, SYM-1219, as a potential treatment for BV," said Robert Jacks, President & CFO of Symbiomix. "The achievement of these milestones keeps the program on track for NDA submission in mid-2016."
The Phase 2 clinical trial was 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 showed that a single oral dose of SYM-1219 was well tolerated and achieved clinically meaningful and highly statistically significant results across primary and secondary endpoints. Symbiomix plans to submit the data to an upcoming medical meeting where additional information will be shared.
BV is the most prevalent gynecological infection in the U.S., affecting almost 30 percent of women of child-bearing age each year. The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks including increasing the risk of HIV transmission and, among pregnant women, increasing the risk of preterm birth [6]. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent [3]. Poor adherence to anti-infective therapy can lead to treatment failures, recurrent disease and the more rapid development of resistant microorganisms [4]. Currently, up to 50 percent of women treated for BV will experience recurrence within 12 months [1,2].
"There has been little innovation in the treatment of serious women's health infections for several decades," said Symbiomix Chief Medical Officer Carol J. Braun, M.D. "The results of our Phase 2 study demonstrate the potential of SYM-1219 to be the first effective, oral, single-dose treatment for BV. We believe that SYM-1219 can improve treatment outcomes for this infection that affects more than 20 million women in the U.S. each year."
During a recent End-of-Phase-2 meeting with the FDA the company received guidance on requirements for an NDA filing for SYM-1219 for the treatment of BV. Based on the robust results of the Phase 2, Symbiomix now plans to submit the trial as one of two pivotal studies. The Company plans to complete one additional Phase 3 trial in 2015 prior to an NDA filing in 2016.
Additionally, the FDA recently granted QIDP designation to SYM-1219 for the treatment of BV. QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act in 2012 to provide incentives for the development of new drugs intended to treat serious or life-threatening infections. 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 NCE market exclusivity.
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