In vivo and in vitro data show SCY-078’s favorable profile and potential therapeutic benefit
JERSEY CITY, N.J., Oct. 05, 2017 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today presented new data for SCY-078, the Company’s lead product candidate, at IDWeek 2017, October 4-8, 2017 in San Diego, CA. SCY-078 is the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family in clinical development for the treatment of several fungal infections, including invasive candidiasis, invasive aspergillosis and vulvovaginal candidiasis.
“The data presented at IDWeek demonstrate the broad activity and potential clinical utility of SCY-078 against invasive Candida and Aspergillus infections as well as the significant tissue distribution of oral and IV SCY-078,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “These results further support our ongoing clinical development of SCY-078 and broaden its potential applicability for multiple fungal infections, including those infections that are invasive and treatment-resistant.”
“The increasing rates of resistance observed in Candida and Aspergillus species to available therapies create an urgent need for novel antifungal agents,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “These results reinforce the potency of the SCY-078 platform and emphasize our strong commitment to advancing the development of SCY-078 as quickly as possible so that patients struggling with these severe infections have viable treatment options.”
SCY-078 Shows Potent Activity Against Invasive Aspergillus (IA)
The first poster, “SCY-078 Demonstrates Significant Antifungal Activity in a Murine Model of Invasive Aspergillosis,” details results of a study designed to evaluate the in vivo antifungal activity of oral SCY-078 in a neutropenic murine model of IA. SCY-078 demonstrated potent activity against wild-type (WT) and azole-resistant strains of A. fumigatus, achieving the primary endpoint of survival at day 14 as well as secondary endpoints of change in fungal kidney burden and serum galactomannan index. These encouraging results support the continued development of oral SCY-078 as a treatment for Aspergillus infections.
SCY-078 Shows Compelling Activity Against WT, Azole-Resistant and Echinocandin-Resistant C. parapsilosis Strains
The second poster, “Assessment of the In Vitro Antifungal Activity of SCY-078 Against a Collection of Candida parapsilosis Clinical Isolates,” details results of a study designed to evaluate the in vitro antifungal activity of SCY-078 against a collection of 206 clinical C. parapsilosis isolates. SCY-078 demonstrated significant activity, as measured by minimum inhibitory concentrations (MIC), against C. parapsilosis isolates, including WT, azole-resistant and echinocandin-resistant strains.
SCY-078 Shows Significant Tissue Penetration Following Oral or IV Administration
The third poster, “SCY-078 Demonstrates Significant Tissue Penetration in Rats and Mice Following Oral or IV Administration,” details results of several studies designed to evaluate tissue distribution of SCY-078 in rats and mice following oral or IV administration. In both models, SCY-078 demonstrated significant tissue penetration at clinically meaningful levels in various target organs. Specifically, the concentrations observed in lung, vaginal tissue and kidney, among other tissues, exceeded the plasma concentrations several fold. These results reinforce the potential therapeutic benefit of orally and intravenously administered SCY-078 for both treatment and prophylaxis of invasive fungal infections.
All presentations are available on the Scientific Publications page of the SCYNEXIS website.
SCY-078 is an antifungal agent in clinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078 is a triterpenoid, semi-synthetic derivative of the natural product enfumafungin – a structurally distinct and novel class of glucan synthase inhibitor. SCY-078 combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having IV and oral formulations. By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.
SCYNEXIS, Inc. is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry, discovering and developing more than 30 innovative medicines over a broad range of therapeutic areas. The Company’s lead product candidate, SCY-078, is the first representative of a novel triterpenoid antifungal family and is in Phase 2 clinical development for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release maybe, “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. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS’ ability to successfully develop SCY-078, including SCYNEXIS’ ability to resolve the FDA’s concerns to lift the clinical hold on the IV formulation of SCY-078 on a timely basis, if at all, and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS’ reliance on third parties to conduct SCYNEXIS’ clinical studies. These and other risks are described more fully in SCYNEXIS’ filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption “Risk Factors” 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.
MacDougall Biomedical Communications
Source: SCYNEXIS, Inc.