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news.Viamet Pharmaceuticals has secured Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US Food and Drug Administration (FDA) for VT-1161 to treat recurrent vulvovaginal candidiasis (RVVC).
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QIDP status offers for an additional five years of market exclusivity, if approved. Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the new drug application.
VT-1161 is an orally available antifungal agent that inhibits a metalloenzyme target dubbed fungal CYP51. It blocks the production of ergosterol, an essential part of the fungal cell membrane.
It demonstrated high potency and selectivity in in vitro studies. In preclinical trials, VT-1161 showed broad-spectrum activity against dermatophytes, including the most common species that cause onychomycosis, and against Candida species, including azole-resistant strains, which frequently cause RVVC.
Viamet Pharmaceuticals CEO Robert Schotzinger said RVVC affects an estimated 5 % to 8% of women of child-bearing age in the US.
Schotzinger said: “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.
“We are very pleased with the FDA’s decision to grant QIDP and Fast Track designations to VT-1161, and look forward to the continued development of this novel therapy.”
Apart from VT-1161, Viamet is also developing VT-1129 and VT-1598.
VT-1129 is currently in phase 1 testing to treat cryptococcal meningitis, a life-threatening fungal infection of the brain. VT-1598 is indicated to treat coccidioidomycosis, or Valley Fever.