SCYNEXIS Data Presentations at ECCMID 2018 Show SCY-078 Potent and Synergistic Antifungal Activity Against Aspergillus and Pneumocystis
Published study further demonstrates in vitro activity of SCY-078 against Aspergillus strains when used alone or in combination
Clinical efficacy against Aspergillus strains to be tested in Phase 2 trial to begin in third quarter of 2018
Antifungal activity against Pneumocystis supports potential use for prophylaxis indications
JERSEY CITY, N.J., April 23, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today announced data presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 21-24, 2018, in Madrid, Spain. SCY-078, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment of several serious fungal infections, including invasive candidiasis, invasive aspergillosis, refractory invasive fungal infections and vulvovaginal candidiasis. The Company also announced the publication of results from a study evaluating the activity of SCY-078 both alone and in combination with other antifungal therapies in over 300 Aspergillus strains in the journal Antimicrobial Agents and Chemotherapy.
"The data presented at ECCMID, together with the recently published study results, contribute to a growing body of evidence supporting SCY-078's potent antifungal activity and showcase its synergy with azole therapy against Aspergillus strains, which are associated with high mortality and increasing rates of resistance to existing therapeutic options," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "We are committed to leveraging SCY-078's versatility and to exploring additional indications for which SCY-078 may benefit patients suffering from serious fungal infections. With regard to Aspergillus infections, we plan to study SCY-078's activity in treating invasive aspergillosis in a Phase 2 clinical trial and remain on track to initiate in the third quarter of this year."
Poster Title: "In Vitro Activity of SCY-078, a Novel IV/Oral Glucan Synthase Inhibitor, against Aspergillus spp., Alone or in Combination with other Antifungal Therapies"
The poster highlights results of a study designed to evaluate the in vitro activity of SCY-078, alone or in combination with amphotericin B, isavuconazole or voriconazole, against 311 Aspergillus strains. SCY-078 demonstrated potent antifungal activity against these isolates independently and synergistic behavior was observed in combination with amphotericin B, voriconazole and isavuconazole.
Poster Title: "Activity of SCY-078 and comparators against a collection of Aspergillus spp., including cryptic species and Cyp51A mutants"
The poster highlights results from a study designed to evaluate the in vitro activity of SCY-078 against 172 Aspergillus strains, including cryptic species and azole-resistant A. fumigatus isolates (Cyp51A mutants). SCY-078 demonstrated activity against most cryptic species and all azole-resistant A. fumigatus isolates.
Poster Title: "SCY-078 Demonstrates Antifungal Activity Against Pneumocystis in a Prophylactic Murine Model of Pneumocystis Pneumonia"
The poster highlights results from a study designed to evaluate the in vivo activity of oral SCY-078 against Pneumocystis pneumonia, a significant risk for immunocompromised patients. Oral SCY-078 was evaluated at three dose levels (7.5mg/kg, 15mg/kg or 30mg/kg, twice daily), compared to trimethoprim/sulfamethoxazole 50/250mg/kg three times weekly, the current standard of care, and vehicle control. At each dose level, oral SCY-078 demonstrated activity against Pneumocystis pneumonia, as determined by a reduction in organism burden and improved survival, supporting future clinical studies of SCY-078 for prophylaxis.
All presentations are available on the Scientific Publications page of the SCYNEXIS website.
In the study, "SCY-078, a Novel Oral Glucan Synthase Inhibitor, for the Treatment of Invasive Aspergillosis: Evaluation of Antifungal Activity Singly and in Combination," researchers provide a comprehensive evaluation of the in vitro activity of SCY-078 against different Aspergillus species, including azole-resistant isolates. Results illustrated SCY-078's potent antifungal activity against a large panel of isolates at concentrations indicative of a potential clinically-relevant effect. SCY-078 was also evaluated in combination with isavuconazole, voriconazole and amphotericin B in clinical strains of A. fumigatus, including azole-resistant strains. The combination of SCY-078 with each of the three agents generally displayed synergistic activity against the isolates tested.
SCY-078 is an investigational antifungal agent that is a semi-synthetic derivative of the natural product enfumafungin. SCY-078 is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having IV and oral formulations. SCY-078 is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum of anti-fungal activity, in vitro and in vivo, against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The FDA 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. (NASDAQ: SCYX) 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 a novel IV/oral antifungal agent in Phase 2 clinical and preclinical development for the treatment of several serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding expected future events or results, including but not limited to the Company's plans regarding clinical developments, potential LPAD designation and timing of data review for the FURI and CARES trials, are "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's ability to successfully develop and obtain FDA approval for SCY-078; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS's reliance on third parties to conduct SCYNEXIS's clinical studies. These and other risks are described more fully in SCYNEXIS's 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.
George E. MacDougall
MacDougall Biomedical Communications
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Released April 23, 2018