Lupin's Solosec meets in Phase III for bacterial vaginosis

In September, Symbiomix Therapeutics LLC -- now part of Lupin Ltd. (NSE:LUPIN; BSE:500257) -- reported data from the Phase III SYM-1219-301 trial in 189 women with bacterial vaginosis showing that 2 g oral Solosec secnidazole met all primary and secondary endpoints vs. placebo. Later in September, FDA approved Solosec, a granule formulation of a next-generation 5-nitroimidazole antibiotic, to treat bacterial vaginosis (see BioCentury, Oct. 13).

In the trial, Solosec led to a clinical responder rate of 53.3% vs. 19.3% for placebo in the modified intent-to-treat (mITT) population (p<0.001). The rates were 58.9% for Solosec vs. 24.6% for placebo when women with abnormal discharge that is inconsistent with bacterial vaginosis were included as responders (p<0.0001). Solosec also increased clinical cure rates based on 2016 FDA guidance of 7-14 days after treatment (64% vs. 26.4%) and decreased the need for additional treatment according to investigator’s clinical assessment (68% vs. 29.6%, p<0.001) vs. placebo. The double-blind, U.S. trial evaluated clinical outcome responder rate as its primary endpoint. Secondary endpoints included Nugent score, therapeutic outcome responder rate, safety and investigator’s clinical assessment...