New Study Further Demonstrates In Vitro Activity of SCYNEXIS’ Lead Anti-Infective Candidate, SCY-078, Against Drug-Resistant Candida Fungal Strains
Supports SCY-078’s Activity Against Emerging Echinocandin-Resistant Candida Species
JERSEY CITY, N.J., June 15, 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 announced the publication of results from a study evaluating the activity of SCY-078 against three hundred and fifty-one Candida clinical isolates from eleven different species, including forty-four echinocandin-resistant strains. In this study, published in the Antimicrobial Agents and Chemotherapy (AAC) medical journal, researchers determined that SCY-078, the first representative of a novel intravenous (IV)/oral triterpenoid antifungal family, has potent in vitro activity against a range of Candida species, including echinocandin-resistant strains, demonstrating SCY-078’s broad spectrum of activity.
“With the growing emergence of non-albicans Candida and antifungal resistance seen in hospitals in the United States, Europe and Asia, it is clear that exposure to azoles and echinocandins is resulting in a rise in these invasive and treatment-resistant fungal infections,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “These results support SCY-078’s broad spectrum of activity against medically relevant Candida spp. including isolates carrying FKS gene mutations, that decrease sensitivity to current front-line therapies. These findings suggest that SCY-078 may prove to be an effective treatment strategy for Candida infections associated with prior treatment failure and high mortality rates.”
In the study, “Differential Activity of the Oral Glucan Synthase Inhibitor SCY-078 against Wild-Type (WT) and Echinocandin-Resistant Strains of Candida spp.,” researchers evaluated the in vitro activity of SCY-078 against three hundred and fifty-one WT and echinocandin-resistant isolates of eleven species of Candida. The study illustrated SCY-078’s potent activity across a broad range of fungal strains at concentrations indicative of a potentially clinically-relevant effect. Specifically, among C. glabrata isolates carrying FKS alterations, 84% were non-WT to the echinocandins compared with only 24% for SCY-078. In contrast to echinocandin comparators, the activity of SCY-078 was minimally affected by the presence of FKS mutations suggesting that SCY-078 may be useful in the treatment of Candida infections, particularly echinocandin-resistant strains.
“These data showcase SCY-078’s broad spectrum of activity across a range of Candida isolates, further supporting our commitment to the development of this novel anti-infective and its potential to impact how life-threatening infections are treated,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Given that echinocandin treatment is only available in an IV formulation, the addition of an agent like SCY-078, potentially available both orally and intravenously, for therapeutic protocols could serve to reduce prolonged hospital stays for patients undergoing anti-fungal therapy.”
SCY-078 is an oral and IV 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 (similar to echinocandins) with the potential flexibility of having IV and oral formulations (similar to azoles). 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 oral and IV formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.
About Invasive Candida Infections
Invasive candidiasis is a serious, often life-threatening infection caused by Candida species that typically affects a highly vulnerable population such as immunocompromised patients or patients under intensive care in hospital settings. The U.S. annual incidence is estimated to be approximately 100,000 cases with high mortality rates (i.e., 20-40%) despite currently available antifungal agents. Furthermore, the limited number of antifungal drug classes, consisting of azoles, echinocandins and polyenes, and their widespread use, has led to increased numbers of candida infections with drug-resistant strains. The Centers for Disease Control has listed fluconazole-resistant Candida as a serious public health threat requiring prompt and sustained action.
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 intravenous and oral 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 may be, "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.
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Released June 15, 2017