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Symbiomix Therapeutics Doses First Patient in Confirmatory Phase 3 Pivotal Study of Lead Drug Candidate SYM-1219 for Bacterial Vaginosis – kcentv.com – KCEN HD – Waco, Temple, and Killeen

By June 9, 2015News
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Symbiomix Therapeutics today announced the dosing of the first patient in a Phase 3 clinical trial, the second of two planned pivotal trials for its lead drug candidate SYM-1219 for the treatment of bacterial vaginosis (BV). Symbiomix previously announced that it plans to submit the multi-center, randomized Phase 2 trial completed last year as one of two pivotal trials required for a New Drug Application (NDA) filing. This Phase 3 trial is the second pivotal study to support an NDA submission for BV. SYM-1219 is a novel drug candidate that contains secnidazole, an antibiotic with favorable pharmacokinetics (PK) allowing for single-dose oral therapy in a condition that is marked by high recurrence rates and low adherence to the current recommended treatment.

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