Symbiomix Therapeutics 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.
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