Viamet has announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designation to VT-1161, a novel treatment for recurrent vulvovaginal candidiasis (RVVC).

There are currently no approved therapies in the U.S. for RVVC, or recurrent vaginal yeast infection, a common and difficult to treat condition.  “The large number of women afflicted by this condition, combined with the lack of approved therapies, highlight the immense need for a safe and effective treatment for RVVC,” said Robert Schotzinger, MD, PhD, and CEO of Viamet. It is estimated that 5 to 8% of women of child-bearing age in the U.S. are affected by RVVC. 

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VT-1161 is a potent and selective, orally-administered inhibitor of fungal CYP51, which blocks the production of ergosterol, an essential component of the fungal cell membrane. 

A Phase 2b test of VT-1161 for the oral treatment of RVVC  and onychomycosis – a highly prevalent fungal infection of the nail – is nearing completion. In preclinical studies, VT-1161 has demonstrated broad-spectrum activity against both Candida and dermatophyte species.

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