SCYNEXIS Presents New In Vivo Data Highlighting the Potential of SCY-078 Used in Combination for the Treatment of Aspergillus Infections at AAA 2018
Data shows synergistic activity and improved outcomes of SCY-078 in combination with isavuconazole
Phase 2 trial in invasive aspergillosis expected to initiate in the third quarter of 2018
JERSEY CITY, N.J., Feb. 1, 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 new preclinical data supporting the potential of SCY-078, the Company's lead product candidate, for the treatment of Aspergillus infections at the 8th Advances Against Aspergillosis (AAA), February 1-3, 2018, in Lisbon, Portugal. 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 oral presentation, titled "Combination Therapy with SCY-078 and Isavuconazole for Treatment of Experimental Invasive Pulmonary Aspergillosis," delivered by the infectious diseases translational research team from Weill Cornell Medicine of Cornell University, describes the results of a study designed to evaluate the in vivo efficacy of SCY-078 in combination with isavuconazole (ISA), an azole used for the treatment of invasive pulmonary aspergillosis (IPA).
- Date and Time: Thursday, February 1 from 14.55-15.10 WET
- Session: Therapy for the Next Decade
"The data presented at AAA show synergistic activity of SCY-078 at two different doses in combination with ISA against Aspergillus in a relevant in vivo model, suggesting the potential for improved patient outcomes for this high-mortality infection with significant unmet medical need," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "Specifically, the combination resulted in significantly prolonged survival, decreased pulmonary injury, and lower serum galactomannan antigenemia (GMI). SCY-078's profile, encompassing broad activity against Aspergillus spp., including azole-resistant strains, favorable safety profile with minimal drug-drug interactions, high pulmonary tissue penetration and oral bioavailability, renders it an optimal candidate for combination therapy for the treatment of invasive aspergillosis. We remain committed to maximizing the therapeutic versatility of SCY-078, and we plan to evaluate oral SCY-078 in combination with a mold-active azole for this indication in a Phase 2 trial on track to initiate in the third quarter of this year."
In the in vivo study, conducted using an established model of experimental IPA, neutropenic rabbits were divided into four experimental study groups where treatment involved either a daily IV administration of a low (2.5mg/kg/day) or high dose (7.5mg/kg/day) of SCY-078; a single dose (40mg/kg/day) of ISA; a combination of either the low or high dose of SCY-078 with ISA; or no treatment as part of the untreated control group. The following results were observed:
- Prolonged survival in rabbits treated with both combination groups compared to all single-therapy arms (p<0.05);
- Decreased infarct scores in rabbits treated with both combination groups compared to all single-therapy arms (p<0.01); and
- Lower serum GMI in rabbits treated with combination regimen of SCY7.5+ISA40 compared to the single therapy arms of SCY7.5, ISA40, and untreated controls (p<0.05).
These results further confirm in vitro data that demonstrated the synergistic and additive activity of SCY-078 in combination with ISA against Aspergillus spp.
The presentation is available on the Scientific Publications page of the SCYNEXIS website.
About SCY-078
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.
About SCYNEXIS
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 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, to 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 February 1, 2018