SCYNEXIS announced the dosing of the first patient with a Candida auris infection, an emerging life-threatening and multidrug-resistant fungal pathogen, in a Phase 3 open-label study evaluating oral ibrexafungerp (formerly SCY-078) in patients with candidiasis caused by C. auris (the CARES Study). Ibrexafungerp, 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.
The CARES study is a multi-center (U.S. and India), open-label, single-arm study designed to evaluate the efficacy, safety and tolerability of oral ibrexafungerp in subjects with documented C. auris infections.
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"The need for effective new therapies for C. auris infections is clear, as the mortality rate for those infected is up to 60% and many strains have been reported to be resistant to drugs from all commercially available antifungal classes," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "Ibrexafungerp has shown potent in vitro activity against C. auris, including in strains resistant to other antifungal agents, and we are committed to evaluating its potential to serve as a therapy for patients affected by this difficult-to-treat infection. We thank the investigators for their participation in the CARES study, and we look forward to advancing this important trial."
To date, SCYNEXIS has reported the results of multiple pre-clinical studies demonstrating the potent activity of ibrexafungerp against C. auris:
Centers for Disease Control (CDC) Study, reported in the Antimicrobial Agents and Chemotherapy (AAC) medical journal, evaluated the in vitro activity of ibrexafungerp against a collection of 100 C. auris isolates. Ibrexafungerp showed potent activity against all strains at concentrations similar to clinically relevant doses. Additionally, the study showed that ibrexafungerp retained similar activity against both susceptible and multidrug-resistant strains, including echinocandin-resistant C. auris isolates.
Case Western Reserve University School of Medicine Study, reported in the AAC medical journal, characterized the activity of ibrexafungerp, demonstrating potent activity against all tested C. auris isolates. Additionally, results showed that ibrexafungerp reduced biofilms and biofilm metabolic activity, a notable feature as C. auris infections have been frequently associated with intravenous catheter use.