Lupin Pharmaceuticals Inc. (LUPIN,500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis.
Trichomoniasis is the most common non-viral, curable sexually transmitted infection or STI in the U.S.
According to Lupin, the trial demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec as compared to placebo.
The company noted that the trial met its primary endpoint of microbiological cure at the test-of-cure or TOC visit on study Day 6-12, defined as a negative Trichomonas vaginalis culture.
The predefined primary efficacy endpoint, defined as Microbiological Cure at the Test-Of-Cure visit (Day 6-12) in the modified Intent-To-Treat or mITT population, was 92.2 percent for Solosec (secnidazole) versus 1.5 percent for placebo.
In the per-protocol population, the cure rate was 94.9 percent for for Solosec compared to 1.7 percent for placebo.
Solosec was generally well-tolerated, with the most commonly reported adverse events being vulvovaginal candidiasis (2.7%) and nausea (2.7%). No serious adverse events were observed.
Based on the data, Lupin plans to submit a supplemental New Drug Application or sNDA to the U.S. Food and Drug Administration for Solosec for the treatment of trichomoniasis in the second half of 2020.
Solosec is approved by the FDA to treat bacterial vaginosis or BV in adult women.
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