Eight SCY-078 Data Presentations at ASM Microbe 2017 Confirm Potential of SCYNEXIS’ Lead Agent to Combat Serious and Life-threatening Fungal Infections
JERSEY CITY, N.J., May 24, 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 eight poster presentations at ASM Microbe 2017, June 1 through 5 in New Orleans, LA. All presentations will feature the company’s lead 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 invasive candidiasis, invasive apergillosis and vulvovaginal candidiasis infections.
“Following an active ECCMID 2017, the large set of data to be presented further confirms the versatility of SCY-078 across treatment settings and against a wide array of Candida and Aspergillus fungal species,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-078’s compatibility in combination with other frequently used drugs and high tissue penetration into organ systems where infections occur are significant differentiators for this novel anti-infective. These presentations further support the potential broad applicability of SCY-078 and its ability to be a next-generation agent to fight these infections, including multi-drug-resistant pathogens such as Candida auris.”
Further details on these presentations will be available on the SCYNEXIS website following the event. All abstracts are available on the ASM Microbe 2017 Online Program Planner.
The details of the presentations are as follows:
Title: Pharmacokinetics and Pharmacodynamics in Patients from a Phase 2, Multicenter, Open-Label, Randomized, Comparative Study of Oral SCY-078 vs. Standard-of-Care Following Initial Intravenous Echinocandin Therapy in the Treatment of Invasive Candidiasis (Including Candidemia) in Hospitalized Non-Neutropenic Adults
Date and Time: Friday, June 2 from 12:45 – 2:45 p.m. CDT
Location: Exhibit Hall D
Poster Presentation #: 193
Session: Antimicrobial Pharmacokinetics: Antifungal PK/PD Studies
Title: In Vitro Interaction between SCY-078, Echinocandins and Azoles against Susceptible and Resistant Candida spp. Determined by the Checkerboard Method
Date and Time: Friday, June 2 from 12:45 – 2:45 p.m. CDT
Location: Exhibit Hall D
Poster Presentation #: 248
Session: Mycology: Clinical and Laboratory Studies of Antifungal Drug Resistance
Title: CYP-Mediated Drug Interaction Profile of SCY-078, a Novel Triterpene Glucan Synthase Inhibitor (GSI)
Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT
Location: Exhibit Hall D
Poster Presentation #: 173
Session: Antimicrobial Stewardship and Quality of Care: Antibiotic Safety
Title: Lack of an Effect of SCY-078, a Novel Antifungal Agent on QTc Interval in Healthy Subjects
Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT
Location: Exhibit Hall D
Poster Presentation #: 172
Session: Antimicrobial Stewardship and Quality of Care: Antibiotic Safety
Title: Pharmacokinetics of SCY-078 Following Intravenous Administration in Rabbits: Implications for Treatment of Experimental Invasive Pulmonary Aspergillosis
Date and Time: Saturday, June 3 from 12:15 – 2:15 p.m. CDT
Location: Exhibit Hall D
Poster Presentation #: 231
Session: Mycology: New Antifungal Agents I
Title: Assessment of the In Vitro Antifungal Activity of SCY-078 against a Panel of Susceptible and Resistant, Clinical Candida Isolates from Europe
Date and Time: Sunday, June 4 from 12:15 – 2:15 p.m. CDT
Location: Exhibit Hall D
Poster Presentation #: 308
Session: Mycology: New Antifungal Agents II
Title: SCY-078, a Novel Intravenous and Oral Antifungal Agent, Demonstrates Extensive Tissue Distribution in Rats Following Single Intravenous Infusions and Oral Doses of [14C]SCY-078
Date and Time: Sunday, June 4 from 12:15 - 2:15 p.m. CDT
Poster Presentation #: 309
Session: Mycology: New Antifungal Agents II
Title: Susceptibility Testing of SCY‐078 against Candida Isolates Obtained from a Clinical Study of Oral SCY‐078 vs. Oral Fluconazole in Subjects with Moderate to Severe Vulvovaginal Candidiasis Demonstrates No Resistance Development
Date and Time: Sunday, June 4 from 12:15 – 2:15 p.m. CDT
Location: Exhibit Hall D
Poster Presentation #: 307
Session: Mycology: New Antifungal Agents II
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 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. 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 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. 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: 781-235-3060 cduong@macbiocom.com Investor Relations Susan Kim Argot Partners Tel: 212-203-4433 susan@argotpartners.com
Released May 24, 2017