Primary endpoint successfully achieved in Phase 3 clinical trial of 147 patients
Lupin Pharmaceuticals (Lupin) the US-based wholly-owned subsidiary of Lupin, announced positive top-line results from its pivotal Phase 3 clinical trial to assess efficacy and safety of single-dose Solosec (secnidazole) 2g oral granules in 147 female patients with trichomoniasis.
Trichomoniasis is the most common non-viral, curable, sexually transmitted infection (STI) in the US. The trial demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec as compared to placebo (p<0.001).
Based on the data, Lupin plans to submit a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (US FDA) for Solosec for the treatment of trichomoniasis in the second half of 2020. Solosec is approved by the US FDA to treat bacterial vaginosis (BV) in adult women.
The trial met its primary endpoint of microbiological cure at the test-of-cure (TOC) visit on study Day 6-12, defined as a negative Trichomonas vaginalis culture. The predefined primary efficacy endpoint, defined as Microbiological Cure (i.e., InPouch TV test negative for T. vaginalis) at the Test-Of-Cure visit (Day 6-12) in the modified Intent-To-Treat (mITT) population (all randomised subjects who were culture positive for T. vaginalis and negative for gonorrhea and chlamydia at baseline), was 92.2 per cent (59/64) for Solosec (secnidazole) versus 1.5 per cent (1/67) for placebo (p<0.001). In the Per-Protocol population, the cure rate was 94.9 per cent (56/59) for Solosec (secnidazole) versus 1.7 per cent (1/60) for placebo (p<0.001). Solosec (secnidazole) was generally well-tolerated with the most commonly reported adverse events being vulvovaginal candidiasis (2.7 per cent) and nausea (2.7 per cent). No serious adverse events were observed.
“Trichomoniasis impacts an estimated 3 to 5 million people in the US,” Gregory Kaufman, Senior Vice President, Global Clinical and Medical Affairs, Specialty, Lupin said. “We are encouraged by the topline results of our clinical trial, look forward to finalising the analysis, and working with the FDA to provide a new single-dose therapy option to physicians and patients, to treat this disease.”