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news.The US Food and Drug Administration (FDA) has approved MethylGene's Investigational New Drug (IND) application to initiate Phase 2 clinical trial for MGCD290 to treat acute vulvovaginal candidiasis (AVVC).
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MGCD290 is an oral Hos2 fungal inhibitor and was designed to be co-administered with azoles like fluconazole in order to enhance activity against fungal infections.
The Phase 2 trial will enroll 200 women with moderate to severe AVVC and is planning to begin enrolling patients by the year end.
The preclinical data showed that MGCD290 in combination with fluconazole increased cidality and broadened the spectrum of azole activity in vitro against human fungal pathogens, including azole-resistant clinical isolates such as Candida glabrata.
MethylGene president and CEO Charles Grubsztajn said they look forward to announce the start of randomized, placebo-controlled, Phase 2 clinical trials for MGCD290 in the near future.
"We expect to report data from this first study in 2012, and to start a second Phase 2 trial with MGCD290 in recurrent vulvovaginal candidiasis in the new year," Grubsztajn said.