Oral presentation of Phase 2 study discusses oral SCY-078 in patients with invasive candidiasis
Potent in vitro activity of SCY-078 against multidrug-resistant fungal pathogen Candida auris
In vitro synergy of SCY-078 in combination with other antifungals against Aspergillus
Additional posters present SCY-078’s broad spectrum of activity and favorable safety profile
JERSEY CITY, N.J., April 12, 2017 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and life-threatening infections, today announced eight data presentations at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 22 to 25, 2017, in Vienna, Austria.
All presentations will feature data related to the development of the company’s lead product candidate, SCY-078, 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 serious and life-threatening invasive fungal infections.
“SCY-078 is proving to be broad spectrum, active against resistant strains, versatile as both IV and oral treatments with high tissue distribution, fungicidal activity and a favorable safety profile,” said Marco Taglietti, M.D., president and CEO of SCYNEXIS. “Our significant presence at ECCMID emphasizes our strong ties to the scientific community and our commitment to delivering novel products to treat these life-threatening fungal infections, including new and multi-drug-resistant pathogens like C. auris that are becoming a major global threat. The SCYNEXIS’ scientific team, in collaboration with renowned academic centers, has generated valuable data that reinforce the unique attributes of SCY-078, a promising candidate offering the potential to positively impact the way severe fungal infections are treated.”
Along with the oral data presentation detailed below, SCYNEXIS will provide an overview of its pipeline and recent advances in the ECCMID 2017 Pipeline Corner at 1:00 p.m. CEDT on Sunday, April 23.
All abstracts are available on the ECCMID website at www.eccmidlive.org.
Oral Presentations
Title: A prospective, phase 2, multicentre, open-label, randomized, comparative study to estimate the safety, tolerability, pharmacokinetics, and efficacy of oral SCY-078 vs standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis (including candidaemia) in hospitalized non-neutropenic adults (mycoses study group 010)
Date and time: Tuesday, April 25 from 9:00 – 9:10 a.m. CEDT
Location: Hall F
Presentation number: OS0846
Session: Challenges in antifungal treatment
Title: The emerging Candida auris: antifungal activity of SCY-078, a novel glucan synthesis inhibitor, on growth morphology and biofilm formation
Date and time: Monday, April 24 from 1:42 – 1:47 p.m. CEDT
Location: ePoster Arena 5
Presentation number: EP0698
Session: Candida infections: from changing epidemiology to changing treatment
Posters
Title: Evaluation of the antifungal activity of SCY-078 in combination with other antifungals against Aspergillus strains
Date and time: Saturday, April 22 from 8:45 – 3:30 p.m. CEDT
Location: ePoster Viewing Area
Poster number: EV0123
Session: Fungal infection & disease
Title: A multicentre, randomized, evaluator-blinded, active-controlled study to evaluate the safety and efficacy of oral SCY-078 in subjects with moderate to severe vulvovaginal candidiasis
Date and time: Tuesday, April 25 from 12:30 – 1:30 p.m. CEDT
Location: Paper Poster Area
Poster number: P1742
Session: Antifungal drugs and treatment II
Title: Effect of SCY-078 on the pharmacokinetics of CYP2C8 substrate (rosiglitazone), results from a phase 1 clinical trial
Date and time: Tuesday, April 25 from 12:30 – 1:30 p.m. CEDT
Location: Paper Poster Area
Poster number: P1713
Session: Antifungal drugs and treatment I
Title: Effect of SCY-078 on the pharmacokinetics of tacrolimus, results of a phase 1 drug-drug Interaction clinical trial
Date and time: Tuesday, April 25 from 12:30 – 1:30 p.m. CEDT
Location: Paper Poster Area
Poster number: P1738
Session info: Antifungal drugs and treatment II
Title: Activity of SCY-078 against Candida spp. obtained by EUCAST and CLSI procedures
Date and time: Tuesday, April 25 from 12:30 – 1:30 p.m. CEDT
Location: Paper Poster Area
Poster number: P1761
Session: Antifungal resistance
Title: The novel oral glucan synthase inhibitor SCY-078 shows in-vitro activity against Candida spp. biofilms
Date and time: Tuesday, April 25 from 12:30 – 1:30 p.m. CEDT
Location: Paper Poster Area
Poster number: P1762
Session: Antifungal resistance
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 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 Candidiasis 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. We estimate that the U.S. annual incidence is 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 and Prevention (CDC) 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., a biotechnology company committed to delivering innovative anti-infective therapies that will transform treatment paradigms and positively impact the lives of patients suffering from difficult-to-treat and life-threatening infections. The SCYNESIS 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 regarding the expected benefits and efficacy of SCY-078 are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because these statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by these 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 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.
CONTACT: CONTACT: Media Relations Cammy Duong MacDougall Biomedical Communications Tel: 781-235-3060 cduong@macbiocom.com Investor Relations Susan Kim Argot Partners Tel: 212-203-4433 susan@argotpartners.com
