New study results demonstrate low risk of interactions between SCY-078 and drugs metabolized by CYP enzymes
| JERSEY CITY, N.J., June 6, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company developing innovative therapies for difficult-to-treat and often life-threatening infections, today 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. 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 the presence and absence of repeat dosing of SCY-078, was generally well tolerated. “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.” “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.” About SCY-078 About SCYNEXIS Forward Looking Statement CONTACT: Investor Relations Media Relations View original content:http://www.prnewswire.com/news-releases/scynexis-announces-the-publication-of-phase-1-study-results-for-scy-078-in-the-journal-of-clinical-pharmacology-300660473.html SOURCE SCYNEXIS, Inc. |
Company Codes: NASDAQ-NMS:SCYX |
