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SCYNEXIS Announces Advancement of Ibrexafungerp’s Intravenous Formulation to Clinical Stage and Provides Further Updates on its Clinical Studies in Patients with Life-Threatening Fungal Infections
Approval granted by health authority for the intravenous (IV) formulation of ibrexafungerp to enter Phase 1; dosing in healthy volunteers to start in the
About this update from Scynexis, Inc.
[{"type":"text","content":"Approval granted by health authority for the intravenous (IV) formulation of ibrexafungerp to enter Phase 1; dosing in healthy volunteers to start in the first quarter of 2021 New interim analysis of the data from the Phase 3 studies of ibrexafungerp in refractory invasive fungal infections (FURI and CARES) expected in the first quarter of 2021; additional 43 patients will double the existing dataset of 41 cases already analyzedAnalysis of the CARES study will provide the first clinical trial data of an investigational treatment against infections caused by Candida auris, a multidrug-resistant fungus deemed an urgent threat by the CDC JERSEY CITY, N.J., Dec. 10, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced significant progress on the ibrexafungerp IV formulation and provided an update on its ongoing Phase 3 studies in the hospital setting. (1) Liposomal IV formulation of ibrexafungerp entering Phase 1 studySCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. SCYNEXIS has been granted approvals from the health authority and ethics committee, with dosing anticipated to start in the first quarter of 2021. (2) New interim analysis of Phase 3 FURI and CARES open-label studies expected in the first quarter of 2021, doubling the existing dataset of patient cases SCYNEXIS has collected data for another 43 patients who have completed treatment in the FURI and CARES open-label studies, and a Data Review Committee (DRC) of independent experts is assessing the efficacy of oral ibrexafungerp in this combined third interim analysis. The FURI study is evaluating oral ibrexafungerp as a salvage treatment in patients with a variety of difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to, intolerant of current standards of care, or require a non-azole oral step-d...