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FDA grants fast track designation for single-dose bacterial vaginosis drug
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Symbiomix Therapeutics announced that the FDA has granted fast track designation to its single-dose bacterial vaginosis therapy, SYM-1219.
The company also recently completed enrollment for its phase 3 clinical trial of the drug, according to a press release.
“The Symbiomix team has executed an aggressive timeline to drive SYM-1219 toward the market,” Robert Jacks, president of Symbiomix, said in the release. “Completing patient enrollment in this phase 3 trial in less than 4 months, and achieving FDA fast track designation, are important milestones against our goal of filing a new drug application by the middle of next year.”
According to the company, SYM-1219 is a novel drug candidate that contains secnidazole, a next-generation, 5-nitroimidazole antibiotic.
The randomized, prospective, double blind, multicenter, placebo-controlled trial will test a single oral dose of SYM-1219 as a complete course of therapy, according to the release. Researchers will examine 189 women diagnosed with bacterial vaginosis for clinical response 21 to 30 days after treatment.
Earlier this year, the FDA designated SYM-1219 a qualified infectious disease product, or QIDP, which would give Symbiomix a 5-year extension of market exclusivity.
“The ability to safely and effectively treat bacterial vaginosis with a single oral dose of SYM-1219 would be an important clinical breakthrough,” Carol J. Braun, MD, chief medical officer of Symbiomix, said in the release.