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Scynexis is a New Jersey-based biotechnology company focused on developing innovative therapies for the treatment of incurable and often life-threatening diseases. Recently, the company announced the positive results of the first interim analysis of the first phase OF clinical study OFI of ibrexafungerp's treatment of fungal infections.ibrexafungerp is an experimental antifungal drug and the first representative of the uniquely structured glucosin synthase inhibitor triterpenoids. ibrexafungerp combines the good activity of glucosin synthase inhibitors with the potential flexibility of oral and intravenous dosing. Currently, the drug is being developed to treat fungal infections caused by false silk yeast (Candida) and asmycin genus. In vitro and in vivo studies, the drug exhibits broad-spectrum antifactoxic activity. Previously, the FDA had qualified ibrexafungerp for qualified infectious disease products (QIDP) and orphan drugs.ibrexafungerp Molecular Structure FURI is an ongoing Open Label PHASE III study designed to assess the efficacy and safety of ibrexafungerp as a treatment drug to treat patients with refractic mucosa skin and invasive fungal infections that are insensitive or insensitive to current available standards of care. The Independent Data Review Board (IDRC) assessed the efficacy of the first 20 patients of ibrexafungerp oral therapy.The 20 patients received oral treatment at ibrexafungerp for periods from 7 to 90 days, with an average duration of 36.4 days, of which 17 showed clinical benefits, of which 11 achieved complete or partial remission and 6 patients were in stable condition. Only 2 patients responded to ibrexafungerp treatment, and the results were uncertain in 1 case. In the study, ibrexafungerp was well-to-do with oral medications, with the most common adverse events being gastrointestinal events and no deaths due to sexual fungal disease.Dr. Marco Taglietti, CEO of Scynexis, said, "The positive results of the first interim analysis are consistent with all of our expectations and confirm the efficacy and safety of oral ibrexafungerp treatments in mucosa skin and invasive fungal infections that do not respond to other therapies, including intravenous drugs." Inaddition to confirming ibrexafungerp's ability to treat fungal infections in susceptible patients with other failed medications, these preliminary results support the continued entry of patients into the FURI study to support future NDA submissions and potential regulatory approval through LPAD (Limited Access to Antibacterial and Antifungal Drugs).LPAD is part of the 21st Century Cure Act to promote the development of new antimicrobial drugs to treat serious or life-threatening infections in a limited number of patients with unsecured medical needs. The drug Arikayce from Insmed was approved by the FDA at the end of September 2018, making it the first product to be approved by LPAD. (Bio Valley Bioon.com)Original source:
CYNEXIS Announces Positive Interim Results from Phase 3 Open-Label FURI Study, Showing Oral Ibrexafungerp's Ability to Treat Refractory Fungal To Providean Long to Term IV Therapies