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FDA Grants QIDP & Fast Track Designations for SCY-078 to Treat Vulvovaginal Candidiasis

The FDA has granted QIDP and Fast Track Designations for the oral formulation of SCY-078 for the treatment of vulvovaginal candidiasis.

Recently, the US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the oral formulation of Scynexis’ antifungal agent SCY-078 for the treatment of vulvovaginal candidiasis (VVC) and prevention of recurrence.

“These designations from the FDA for the treatment of VVC and prevention of recurrent VVC highlight the significant unmet needs faced by women suffering from these widespread infections,” Marco Taglietti, MD, president, chief executive officer, Scynexis, said in a recent statement. “We believe SCY-078 will provide a beneficial treatment option for health care providers and women not satisfied with existing therapies. Moreover, we can now make use of the QIDP and fast track designations across all current SCY-078 development programs, including VVC, invasive candidiasis and invasive aspergillosis.”

The novel oral intravenous antifungal agent is a semi-synthetic derivative of the natural product enfumafungin and is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids.

The biotechnology company also announced that it has completed enrollment for the DOVE study, a phase 2b, dose-finding study for the treatment of VVC; they anticipate the top-line data to be released by July 2018.

The DOVE study, which enrolled more than 180 women with moderate to severe acute VVC, aims to assess the efficacy, safety, tolerability, and pharmacokinetics of 5 different regimens of the oral treatment in order to identify optimal dosing for the phase 3 registration program, which is expected to begin in the fourth quarter of 2018.

“With the recent initiation of [the DOVE study], we are continuing to maximize the value of the SCY-078 platform by advancing the oral formulation of SCY-078,” Dr. Taglietti said in a past statement. “The DOVE study is a critical step towards our goal to provide a treatment option for WC patients, particularly those with recurrent VVC, for which there are currently no approved therapies.”

Current treatments include topical antifungals and the use of prescription oral antifungals, such as fluconazole.

SCY-078 is also currently in development for the treatment of fungal infections caused by Candida (including C. auris) and Aspergillus species.

The FDA has granted QIPD and fast track designation for the formulations of SCY-078 for indications of invasive candidiasis, invasive aspergillosis, and VVC, and additionally, has granted orphan drug designation for the invasive candidiasis and invasive aspergillosis indications. The QIDP designation allows Scynexis to have priority review, eligibility for fast-track status and an additional 5 years of market exclusivity in the US.

A previous version of this article has appeared on MDMagazine.com.

Feature Picture Source: CDC / Joe Miller. Feature Picture Caption: This is a Gram-stained photomicrograph of a vaginal discharge specimen. As part of a differential diagnostic study, after its analysis, a diagnosis of genital-vulvovaginal candidiasis (VVC) was determined to be this patient’s malady, which had been caused by an overgrowth of Candida albicans organisms. Note the Gram-positive yeast cells, and the budding cell designated by the arrowhead.