JERSEY CITY, N.J., Oct. 15, 2018 /PRNewswire/ — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology aggregation carrying avant-garde therapies for difficult-to-treat and generally life-threatening infections, today appear the dosing of the aboriginal accommodating with a Candida auris infection, an arising life-threatening and multidrug-resistant fungal pathogen, in a Phase 3 open-label abstraction evaluating articulate ibrexafungerp (formerly SCY-078) in patients with candidiasis acquired by C. auris (the CARES Study). Ibrexafungerp, the aboriginal adumbrative of a atypical articulate and intravenous (IV) triterpenoid antifungal family, is in analytic development for the analysis of assorted austere fungal infections, including vulvol candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and adverse invasive fungal infections.
The CARES abstraction is a multi-center (U.S. and India), open-label, single-arm abstraction advised to appraise the efficacy, assurance and tolerability of articulate ibrexafungerp in capacity with accurate C. auris infections (Clinicaltrials.gov NCT03363841).
“The charge for able new therapies for C. auris infections is clear, as the bloodshed amount for those adulterated is up to 60% and abounding strains accept been appear to be aggressive to drugs from all commercially accessible antifungal classes,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “Ibrexafungerp has apparent almighty in vitro action adjoin C. auris, including in strains aggressive to added antifungal agents, and we are committed to evaluating its abeyant to serve as a analysis for patients afflicted by this difficult-to-treat infection. We acknowledge the board for their accord in the CARES study, and we attending advanced to advancing this important trial.”
To date, SCYNEXIS has appear the after-effects of assorted pre-clinical studies demonstrating the almighty action of ibrexafungerp adjoin C. auris:
About Candida auris Candida auris, a fungal ache aboriginal appear in 2009, has been affiliated to invasive fungal infections in several countries, including the U.S., and has acquired at atomic two hospital outbreaks involving added than 30 patients each. The CDC estimates that infections with C. auris are associated with a bloodshed amount of up to 60% and that some strains of this breed of Candida have accurate to be aggressive to all three above classes of antifungal drugs, apprehension analysis difficult. This blazon of ample attrition to accustomed antifungal agents has not been empiric in added breed of Candida. The best accepted blazon of infection acquired by C. auris is in the bloodstream. The CDC is actively tracking C. auris infections globally and has issued an active to all healthcare accessories classifying this new antibody as a austere all-around bloom threat. The accident of C. auris infections in the U.S. is rapidly growing; in aloof the accomplished year, the cardinal of accepted cases appear by the CDC has added than doubled.
For added advice about C. auris, visit: https://www.cdc.gov/fungal/candida-auris/index.html
About Ibrexafungerp (formerly SCY-078)Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal abettor and the aboriginal adumbrative of a atypical chic of structurally-distinct glucan synthase inhibitors, triterpenoids. This abettor combines the absolute action of glucan synthase inhibitors with the abeyant adaptability of accepting articulate and IV formulations. Ibrexafungerp is currently in development for the analysis of fungal infections acquired primarily by Candida (including C. auris) and Aspergillus species. It has approved ample spectrum antifungal activity, in vitro and in vivo, adjoin multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has accepted QIDP and Fast Track designations for the formulations of ibrexafungerp for the break of IC (including candidemia), IA and VVC, and has accepted Orphan Drug Designation for the IC and IA indications.
About SCYNEXISSCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology aggregation committed to absolutely impacting the lives of patients adversity from difficult-to-treat and generally life-threatening infections by developing avant-garde therapies. The SCYNEXIS aggregation has all-encompassing acquaintance in the activity sciences industry, advertent and developing added than 30 avant-garde medicines over a ample ambit of ameliorative areas. SCYNEXIS’s advance artefact candidate, ibrexafungerp (formerly SCY-078), is a atypical oral/IV antifungal abettor in Phase 2 analytic and pre-clinical development for the analysis of assorted austere and life-threatening invasive fungal infections acquired by Candida and Aspergillus species. For added information, appointment www.scynexis.com.
Forward Looking StatementStatements independent in this columnist absolution apropos accepted approaching contest or after-effects are “forward-looking statements” aural the acceptation of the Private Securities Litigation Reform Act of 1995, including afterwards limitation, statements regarding: expectations for the timing of admission of, and dosing in, analytic trials; affairs for analysis of FURI and CARES. Because such statements are accountable to risks and uncertainties, absolute after-effects may alter materially from those bidding or adumbrated by such advanced statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS’s ability to auspiciously advance and obtain FDA approval for ibrexafungerp; the accepted costs of studies and back they ability activate or be concluded; and SCYNEXIS’s assurance on third parties to conduct SCYNEXIS’s clinical studies and to accomplish artefact supplies. These and added risks are declared added absolutely in SCYNEXIS’s filings with the Securities and Exchange Commission, including afterwards limitation, its best contempo Annual Report on Form 10-K beneath the explanation “Risk Factors” and added abstracts afterwards filed with or furnished to the Securities and Exchange Commission. All advanced statements independent in this columnist absolution allege alone as of the date on which they were made. SCYNEXIS undertakes no obligation to amend such statements to reflect contest that action or affairs that abide afterwards the date on which they were made.
Investor RelationsNatalie WildenradtArgot PartnersTel: [email protected]
Media RelationsGeorge E. MacDougallMacDougall Biomedical CommunicationsTel: [email protected]
SOURCE SCYNEXIS, Inc.
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