JERSEY CITY, N.J.—Today SCYNEXIS, Inc., a biotechnology company developing therapies for difficult-to-treat and often life-threatening infections, announced the publication of results from a Phase 1 study of SCY-078, assessing the risk for drug-drug interactions when administered with drugs metabolized by the CYP family of enzymes, in The Journal of Clinical Pharmacology. 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.
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. 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 antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted QIPD and Fast Track designations for the formulations of SCY-078 for the indications of IC (including candidemia), IA and VVC, and has granted Orphan Drug Designation for the IC and IA indications.
“These results are important for the development of SCY-078 and its potential impact in patient populations with specific medical requirements,” said David Angulo, M.D., chief medical officer of SCYNEXIS. “Diabetic women, particularly those with poor glucose control, have increased risks of developing VVC, especially severe and complicated forms. Unfortunately azoles, including fluconazole, the only oral standard of care for VVC, can significantly affect blood levels of many commonly-used antidiabetic drugs like thiazolidinediones, sulfonylureas and dipeptidyl peptidase-4 inhibitors (DPP4s), requiring careful monitoring of blood glucose and precise dose adjustments of these antidiabetic drugs to avoid severe and potentially life-threatening fluctuations. SCY-078 has been shown in this and other drug-drug interaction studies to have little potential for causing clinically meaningful drug-drug interactions, providing a needed alternative to azoles in treating these patients.”
The article, “Lack of Impact by SCY-078, a First-in-Class Oral Fungicidal Glucan Synthase Inhibitor, on the Pharmacokinetics of Rosiglitazone, a Substrate for CYP450 2C8, Supports the Low Risk for Clinically Relevant Metabolic Drug-Drug Interactions,” describes the Phase 1 study, in which the pharmacokinetic parameters of rosiglitazone, a thiazolidinedione agent commonly used for type 2 diabetes, were measured in the absence and presence of SCY-078 dosed to therapeutically relevant levels in healthy adult subjects. In this open-label two-period crossover study, results demonstrated that co-administration of rosiglitazone with SCY-078 after repeat dosing had no clinically meaningful effect on rosiglitazone exposure, compared with administration of rosiglitazone alone. SCY-078 was well absorbed following the loading dose, and repeated daily doses of rosiglitazone, in both the presence and absence of repeat dosing of SCY-078, was generally well tolerated.
“These results underscore the broad potential benefit of SCY-078 as an antifungal agent in multiple clinical settings,” said Marco Taglietti, M.D., president and chief executive officer of SCYNEXIS. “For patients dealing with multiple medical issues and polytherapy, these data demonstrate SCY-078’s potential as an alternative to current standards of care, especially when the standard of care is well known to cause clinically meaningful drug-drug interactions. We will continue to evaluate specific patient populations with clear needs as we continue to expand the utility of SCY-078 and look forward to sharing updates on SCY-078’s development, most immediately with the reporting of top-line data in the Phase 2b DOVE trial, evaluating oral SCY-078 for the treatment of VVC, by July, and the start of the VVC Phase 3 program in the fourth quarter.”
According to their website, SCYNEXIS plans to initiate a Phase 2 combo study in IA in the third quarter, as well as a Phase 2 study in IC in the fourth quarter. The FURI & CARES studies preliminary data reviews are also expected in the fourth quarter of 2018.