SCYNEXIS Announces the Presentation of SCY-078 Data at the Teratology Society 58th Annual Meeting
SCYNEXIS Announces the Presentation of SCY-078 Data at the Teratology Society 58th Annual Meeting SCY-078 shows no impact on fertility or early embryonic development in pre-clinical studies, a differentiator vs. current treatments |
[27-June-2018] |
JERSEY CITY, N.J., June 27, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company developing innovative therapies for difficult-to-treat and often life-threatening infections, today announced the presentation of data at the Teratology Society 58th Annual Meeting, June 23-27, 2018 in Clearwater, Florida. SCY-078, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. "The treatment of fungal infections during pregnancy has long been challenging due to the well-known developmental toxicities associated with existing antifungal treatments," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "These studies provide evidence that SCY-078 does not exhibit developmental or reproductive toxicity when administered to animals before and/or during gestation. The absence of teratogenicity is a critical differentiator for SCY-078, as the majority of currently available antifungal therapies, including azoles, are associated with fertility and early embryonic development toxicities." The poster, titled "SCY-078, a Novel IV/Oral Triterpenoid Antifungal Treatment, is Not Embryo/Feto-toxic," describes the results of pre-clinical studies designed to assess the impact of SCY-078 on reproductive potential, mating behavior, and embryonic and fetal development. To assess the impact on reproductive potential, SCY-078 was administered to Wistar rats prior to and during mating; then continuously through early gestation to assess the impact on early pregnancy and to the conceptus. Additionally, to assess the impact of SCY-078 on the embryo-fetal development, SCY-078 was administered to Wistar rats and Dutch-belted rabbits throughout the period of organogenesis. At doses greater than the efficacious clinical exposure, sexual function, maturation of gametes, estrous cycles, pregnancy rates and implantation were comparable to vehicle control; rats and rabbits receiving oral SCY-078 showed no enhanced toxicities relative to those noted in studies conducted with non-pregnant females, there was no increase in embryo-fetal loss, and evaluations of fetal development revealed no SCY-078-related anomalies in the rats or rabbits. "These results represent an important positive first step in determining the safety of SCY-078 use during pregnancy, a critical aspect for female patients and their physicians," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "Oral fluconazole, the standard of care for VVC, has warnings when used by pregnant women or women in child-bearing age, in whom VVC infections occur more frequently. We are extremely encouraged by these results as we continue to work toward advancing the development of oral SCY-078 in VVC and other indications, including reporting the topline results from our Phase 2b DOVE study by July 2018." The poster is available on the Scientific Publications page of the SCYNEXIS website. About the DOVE Study About Vulvovaginal Candidiasis
Current treatments for acute VVC include over-the-counter (OTC) topical azole antifungals (clotrimazole, miconazole, and others) and the use of the prescription oral azole antifungal, fluconazole. Fluconazole is the only orally-administered antifungal currently approved for acute VVC in the U.S., with a therapeutic cure rate of 55% as reported in its label. Uncomplicated acute VVC cases are often effectively treated with topical agents and/or with one to three doses of oral fluconazole. However, management of VVC during pregnancy, moderate-to-severe VVC, recurrent VVC and VVC caused by fluconazole-resistant Candida spp., are not fully addressed by oral fluconazole. In addition, there are no oral alternatives for VVC patients who do not respond to or tolerate fluconazole, and there are no U.S. Food and Drug Administration (FDA)-approved products for the treatment of recurrent VVC. About SCY-078 About SCYNEXIS Forward Looking Statement CONTACT: Investor Relations Media Relations View original content:http://www.prnewswire.com/news-releases/scynexis-announces-the-presentation-of-scy-078-data-at-the-teratology-society-58th-annual-meeting-300672441.html SOURCE SCYNEXIS, Inc. | ||
Company Codes: NASDAQ-NMS:SCYX |
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