Scynexis anti-fungal gets on FDA fast track

DURHAM – An anti-fungal drug candidate from Scynexis is now on a path for faster regulatory review.

The Durham company said that the Food and Drug Administration designated the compound SCY-078 as a “qualified infectious disease product,” or QIDP. This designation allows Scynexis to have priority review, eligibility for fast-track status, and an additional five years of market exclusivity in the U.S. for the compound – if approved.

SCY-078 is being studied to treat invasive Candidiasis, including Candidemia, and invasive Aspergillosis. The compound, Scynexis’ lead product candidate, is entering phase II clinical trials. So far it has shown activity against has shown activity against the two main pathogens responsible for the majority of invasive fungal infections Candida and Aspergillus species, and is an oral and parenteral glucan synthase inhibitor developed for the treatment of invasive fungal infections..

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