Eight Presentations at ASM Microbe 2017 Further Highlight the Strong Antifungal Effect and Promising Safety Profile of Lead Anti-Infective Candidate SCY-078
Potent and broad activity of SCY-078 shown against more than 300 clinical Candida isolates
Multiple studies confirm high compatibility of SCY-078 with other antifungals and favorable safety profile
JERSEY CITY, N.J., June 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 announced the results of eight studies supporting the potent and broad antifungal activity and positive safety and tolerability profile of SCY-078, its lead candidate. SCY-078 is the first representative of a novel intravenous (IV) and oral triterpenoid antifungal family in Phase 2 clinical development for the treatment of several fungal infections, including invasive candidiasis, invasive aspergillosis and vulvovaginal candidiasis (VVC) infections.
"The results presented at ASM Microbe further confirm the versatility and activity of SCY-078 against a range of serious fungal strains as well as its clinically-relevant attributes including high tissue distribution and reduced risk for drug-drug interactions," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "These results support recently published reports from the Centers for Disease Control and Prevention (CDC) and Case Western Reserve University School of Medicine in which SCY-078 was highlighted as a potential treatment for infections caused by multidrug-resistant fungal species, including the global health threat Candida auris."
In the studies presented, SCY-078 showed:
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Potent, broad spectrum antifungal activity and extensive tissue distribution
- SCY-078’s potent and broad in vitro activity against 271 Candida isolates from European centers, with activity retained against multiple azole-resistant and echinocandin-resistant isolates
- Single IV and oral doses in rats resulted in wide distribution of SCY-078 into tissues commonly involved in fungal infections such as lungs, liver, spleen and vagina, supporting continued development for treatment of invasive fungal infections and VVC
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Promising safety profile and low risk of drug-drug interactions
- Potential for SCY-078 to be used in combination with other antifungals, such as azoles and echinocandins, to manage Candida infections
- Minimal risk for CYP-mediated drug-drug interactions with SCY-078, including CYP3A4
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Additional evidence of SCY-078’s positive safety profile
- Safety and tolerability profile and global response rate for SCY-078 similar to standard of care for treatment of invasive candidiasis
- No clinically meaningful effect on QTc when SCY-078 was administered to healthy volunteers
For more information on the programs or to view the posters associated with these data, visit www.SCYNEXIS.com.
About SCY-078
SCY-078 is an oral and IV antifungal agent in Phase 2 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.
About Invasive Aspergillus Infections
Invasive aspergillosis is a serious fungal infection caused by Aspergillus species that usually affects people who have weakened immune systems, such as people who have had an organ transplant or a stem cell transplant. Invasive aspergillosis most commonly affects the lungs, but it can also spread to other parts of the body. There are approximately 50,000 cases of invasive aspergillosis reported in the U.S. annually, with a mortality rate as high as 50%. Current standard of treatment is eight to 12 weeks of azoles usually started as IV treatment for one to two weeks followed by oral step-down treatment for several weeks.
About Vulvovaginal Candidiasis Infections
Vulvovaginal candidiasis (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, 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 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.
CONTACTS: Media Relations Cammy Duong MacDougall Biomedical Communications Tel: 781-591-3443 cduong@macbiocom.com Investor Relations Susan Kim Argot Partners Tel: 212-203-4433 susan@argotpartners.com
Released June 5, 2017