SCYNEXIS, Inc. Initiates Enrollment of the Phase 2 Study of SCY-078 in Vulvovaginal Candidiasis
JERSEY CITY, N.J., Dec. 1, 2015 (GLOBE NEWSWIRE) -- Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today announced that it has initiated enrollment and the first group of patients have been dosed in its Phase 2 study of oral SCY-078 as a treatment for vulvovaginal candidiasis (VVC). SCY-078, SCYNEXIS' novel antifungal drug candidate, is an oral glucan synthase inhibitor and is also in development as both oral and intravenous formulations for the treatment of invasive and life-threatening fungal infections.
"VVC is a highly prevalent condition with 75% of women experiencing at least one episode during their lifetime. No new oral antifungal agents have been approved for this indication in more than 20 years. New treatment options are needed, particularly for patients with recurrent episodes of VVC or those caused by azole-resistant Candida strains," said Dr. Jack Sobel, Professor of Medicine at Wayne State University's School of Medicine. "I'm excited to see SCYNEXIS progressing the development of the oral formulation of this new glucan synthase inhibitor (SCY-078) with significant potential to address these compelling unmet medical needs in the treatment of this condition."
"We believe that SCY-078 has broad clinical utility in multiple disease areas, and we remain committed to advancing this important new treatment option into other indications to fully maximize its potential," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We anticipate that this study will provide further clinical evidence of SCY-078's activity against Candida infections in humans to support the clinical development of this innovative glucan synthase inhibitor as a treatment for fungal infections. We expect to report topline results from this study in the first half of 2016."
About the Study
The Phase 2 study is a randomized, multicenter, evaluator-blinded study of oral SCY-078 compared to oral fluconazole in adult female patients. At least 90 patients with moderate to severe vulvovaginal candidiasis will be enrolled and will receive two different regimens of SCY-078 compared to the current standard of care of oral fluconazole. Patients will be evaluated approximately every 30 days for 120 days or at any time that a recurrence or clinical failure is suspected. The study will assess the efficacy, safety, tolerability and pharmacokinetics of SCY-078 over the trial period.
About SCY-078
SCY-078 (formerly MK-3118) is an oral glucan synthase inhibitor in Phase 2 being developed for the treatment of invasive fungal infections including Candidemia and invasive Aspergillosis, as well as vulvovaginal candidiasis. SCY-078 is a semi-synthetic derivative of the natural product enfumafungin – a structurally distinct class of glucan synthase inhibitors. Glucan synthase inhibitors have been very effective in treating invasive fungal infections in a hospital setting but are currently only available in intravenous formulations. The FDA designated SCY-078 as a Fast Track and Qualified Infectious Disease Product (QIDP) for oral use for the indications of invasive Candidiasis, including Candidemia, and invasive Aspergillosis. SCYNEXIS is developing both oral and intravenous formulations of SCY-078.
About Vulvovaginal Candidiasis (VVC)
VVC, commonly known as a "yeast infection," is usually caused by Candida albicans and typical symptoms include pruritus, vaginal soreness, irritation and abnormal vaginal discharge. An estimated 75% of women will have at least one episode of VVC during their lifetime and 40%–45% will experience two or more episodes. As many as 8% of these patients suffer from recurrent VVC, defined as experiencing at least four episodes a year. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such fluconazole, which has a therapeutic cure rate of 55% as reported in the label. There are no products currently approved for the treatment recurrent VVC.
About SCYNEXIS, Inc.
SCYNEXIS is a pharmaceutical company committed to the development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, as an oral and intravenous (IV) drug for the treatment of a variety of fungal infections in humans. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding matters that are not historical facts, including those statements regarding any future performance of SCYNEXIS's product candidates, the potential of SCY-078 to treat fungal infections, including VVC, the therapeutic and commercial potential of SCY-078, and the anticipated timing and therapeutic and commercial potential of the product candidates of SCYNEXIS are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks related to SCYNEXIS and the development of SCY-078 are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation under the caption "Risk Factors" in its most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT: Media Relations
Heather Savelle
MacDougall Biomedical Communications
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Investor Relations
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Argot Partners
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Released December 1, 2015