SCYNEXIS, Inc. Presents Ibrexafungerp Data at the 2018 ESCMID/ASM Conference on Drug Development
In vitro studies show activity of ibrexafungerp against echinocandin-resistant C. glabrata strains
JERSEY CITY, N.J., Sept. 4, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced the presentation of data at the 2018 European Society of Clinical Microbiology and Infectious Diseases (ESCMID)/American Society for Microbiology (ASM) Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance, September 4-7, 2018, in Lisbon, Portugal. Ibrexafungerp (formerly SCY-078), the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections.
Candida glabrata, the second-most common fungal species isolated from blood in the US, is one of the most common fungal pathogens worldwide and fks mutations are a growing problem leading to echinocandin resistance. The poster presentation, titled "Ibrexafungerp (formerly SCY-078) Displays Potent In Vitro Activity Against C. glabrata Isolates with Mutations in fks Genes," combines the results of several in vitro studies of ibrexafungerp against a total of 79 Candida glabrata strains with fks mutations showing that ibrexafungerp maintains potent activity against these echinocandin-resistant strains when compared to caspofungin and micafungin.
"With the rapidly rising rates of resistance to many standards of care available today, including therapies in the azole and echinocandin classes, the unmet medical need for novel treatment options for severe fungal infections is growing," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "These data, showing the superior activity of ibrexafungerp against several echinocandin-resistant strains, suggest ibrexafungerp has the potential not only to be an effective treatment option for echinocandin-resistant C. glabrata strains, but also to play a pivotal role in the broader effort to develop novel treatment options capable of treating fungal infections caused by resistant strains."
In five independent studies, the in vitro susceptibility, determined by broth micro-dilution, of C. glabrata strains to ibrexafungerp was assessed, including 79 isolates with fks mutations and 142 wild-type isolates. Comparator compounds varied across studies and included caspofungin and micafungin. In these studies, ibrexafungerp demonstrated activity against 78% of C. glabrata isolates with fks mutations, including those with the most commonly observed fks1 and fks2 mutations (S629P and S663P, respectively), a superior rate as compared to both caspofungin and micafungin.
About Ibrexafungerp (formerly SCY-078)
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and 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 oral and IV formulations. Ibrexafungerp 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 antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted QIDP and Fast Track designations for the formulations of ibrexafungerp for the indications of IC (including candidemia), IA and VVC, and has granted Orphan Drug Designation for the IC and IA indications.
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 developing innovative 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. SCYNEXIS's lead product candidate, ibrexafungerp (formerly SCY-078), is a novel oral/IV antifungal agent in Phase 2 clinical and pre-clinical development for the treatment of multiple serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. For more information, visit https://www.scynexis.com/.
Forward Looking Statement
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding: expectations for the timing of initiation of, and dosing in, clinical trials; anticipated timing for filing an initial NDA in 2020; plans to start a study in IA in the third quarter of 2018; plans for review of FURI and CARES . 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 ibrexafungerp; 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 and to manufacture product supplies. 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
SOURCE SCYNEXIS, Inc.
Released September 4, 2018