Pre-clinical data demonstrates inhibitory activity of SCY-078 against C. auris
Two ongoing trials - FURI and CARES - to study oral SCY-078 in patients with refractory fungal infections, including C. auris
JERSEY CITY, N.J., March 20, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today announced new pre-clinical data supporting the potential of SCY-078, the Company's lead product candidate, for the treatment of Candida auris at Superbugs and Superdrugs 2018, March 19-20, 2018, in London, UK. 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 vulvovaginal candidiasis, invasive candidiasis, invasive aspergillosis and refractory invasive fungal infections.
The oral presentation, titled "C. auris – a difficult to treat, emerging pathogen," delivered by Stephen A. Barat, Ph.D., Executive Director of Pre-clinical Research and Early Clinical Development at SCYNEXIS, briefly describes the history and experimental models of C. auris, a pathogen recently classified as a global emerging threat by worldwide health authorities, and highlights the potential of SCY-078 as a novel treatment for this pathogen.
"C. auris is an emerging, multidrug-resistant pathogen associated with a significant mortality rate of up to 60%," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "C. auris strains demonstrated resistance to all three currently available classes of antifungal therapies, underlining the substantial, global, unmet medical need to address this emerging health threat. These data show that SCY-078, a representative of a novel triterpenoid antifungal class, has demonstrated pre-clinical activity against C. auris, including inhibition of C. auris biofilms, interruption of cell division and destruction of internal cellular structures. We remain committed to exploring SCY-078's potential utility as a treatment for this pathogen, as we work to advance both our global, open-label FURI and CARES trials, evaluating oral SCY-078 for the treatment of fungal infections, including those caused by C. auris, in patients who are refractory to or intolerant of standard therapies."
In the pre-clinical study, SCY-078 significantly inhibited C. auris biofilms at all evaluated concentrations, as measured by a reduction in the metabolic activity and the thickness of the biofilms. Additionally, SCY-078 interrupted C. auris cell division, with the organism forming abnormal, fused, fungal cells, as observed by scanning electron microscopy (SEM). SCY-078 also affected the ultrastructure of C. auris, as observed by transmission electron microscopy (TEM), resulting in:
- distortion of the outer cell envelope,
- leakage of cytoplasmic material,
- destruction of the internal cytoplasmic structures, and
- abnormal fused fungal cells, confirming the SEM imaging results.
SCY-078 has been evaluated for in vitro activity against more than 110 C. auris isolates in two previously reported, independent studies, in which SCY-078 showed activity against all C. auris clades with little inter-clade variation in activity. Additionally, SCY-078 demonstrated in vitro activity against C. auris isolates with elevated MIC's to echinocandins.
SCYNEXIS believes compelling data from the FURI and/or CARES trials could allow oral SCY-078 to become eligible for the regulatory Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), potentially resulting in an initial NDA based on streamlined development. SCYNEXIS remains on track to conduct a preliminary data review in both trials in the fourth quarter of 2018.
SCYNEXIS, Inc. (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