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Great news from #Lupin for Phase 3 data on #Solosec for Trichomoniasis. Its supplemental New Drug Application (sNDA). Solosec is currently approved by the FDA to treat bacterial vaginosis (BV) in adult women, so no safety concerns. FDA would look for good efficacy data (1)
Firstly, no new antibiotics are discovered. Humans are under a continuous threat against microbes. Solesec is developed by Symbiomix Therapeutics, Lupin bought it in 2017 for $150M
In the trial, 92% of patients achieved the primary endpoint versus 1.5% in the placebo group (2)
In the trial, 92% of patients achieved the primary endpoint versus 1.5% in the placebo group (2)
The cure rate was 95%(56/59) for Solosec versus 1.7% (1/60) for placebo. Well-tolerated, no serious adverse events were observed in the trial.
If approved, can get 10-year exclusivity. This is big. Most of the topline goes to the bottom line in patented drugs (3)
If approved, can get 10-year exclusivity. This is big. Most of the topline goes to the bottom line in patented drugs (3)
