Drug development company MethylGene has finished enrolling patients suffering from moderate-to-severe vulvovaginal candidiasis (VVC) in its Phase II trial of MGCD290, an orally available, small molecule inhibitor of the fungal enzyme Hos2.
The multi-centre, placebo-controlled trial, 290-005, is designed to asses MGCD290 along with fluconazole versus fluconazole alone in VVC patients.
The randomised, double-blind study enrolled more than 200 patients across 19 sites in North America and the topline data are anticipated in March 2013.
MethylGene president and chief executive officer Dr Chuck Baum said first Phase II trial of MGCD290 finished patient enrolment.
"MGCD290 is a novel antifungal agent with the potential to significantly improve outcomes for patients suffering from fungal infections, including VVC," Dr Baum said.
The primary endpoint for the study is therapeutic cure at Day 28, which is a complex endpoint of clinical cure (resolution of signs and symptoms of the infection) and mycological cure (absence of yeast in culture).
The modified intent to treat (MITT) population, including those who received treatment and were culture positive for yeast at baseline, forms the basis for the primary endpoint of the study.
The secondary endpoints are clinical and mycological cure rates at day 14 and day 28, therapeutic, clinical and mycological cure rates at day 14, recurrence rate at day 28, and time to recurrence.