New study results demonstrate low risk of interactions between SCY-078 and drugs metabolized by CYP enzymes
Results suggest potential clinical relevance of SCY-078 for patients with Type 2 diabetes with VVC
On track to report Phase 2b data in VVC by July 2018, with Phase 3 trial initiation in the fourth quarter of 2018
JERSEY CITY, N.J., June 6, 2018 /PRNewswire/ -- SCYNEXIS, Inc. (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."
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. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. 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.
SCYNEXIS, Inc. (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. The Company's lead product candidate, SCY-078, is a novel IV/oral antifungal agent in Phase 2 clinical and preclinical development for the treatment of multiple serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding expected future events or results, including but not limited to the Company's plans regarding clinical developments, timing of data review for the DOVE trial and possible initiation of a Phase 3 registration program in VVC, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. 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 SCY-078; 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. 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