Business
SCYNEXIS Announces Agreement with FDA on Innovative Strategy for Approval of Oral Ibrexafungerp for Treatment of Invasive Candidiasis
SCYNEXIS is initiating a global Phase 3 study to evaluate oral ibrexafungerp as a step-down treatment for invasive candidiasis (IC), including
About this update from Scynexis, Inc.
[{"type":"text","content":"SCYNEXIS is initiating a global Phase 3 study to evaluate oral ibrexafungerp as a step-down treatment for invasive candidiasis (IC), including candidemia.Study provides an expeditious path toward approval of ibrexafungerp as the first non-azole oral therapy for invasive candidiasis. Approximately 35,000 cases of IC in the U.S. per year are caused by Candida species resistant to azoles, for which ibrexafungerp could provide a much-needed oral alternative. SCYNEXIS will provide an overview of the strategy and answer questions about the clinical development programs during a Hospital Pipeline Update webcast today at 10 a.m. ET. JERSEY CITY, N.J., Dec. 06, 2021 (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 initiation of a global Phase 3 study to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a step-down therapy for patients with invasive candidiasis and/or candidemia following intravenous (IV) echinocandin therapy in the hospital compared to currently-available outpatient therapies. “We believe that ibrexafungerp, with its activity against fluconazole-resistant strains, is perfectly suited to provide a much-needed alternative as a step-down oral treatment for invasive candidiasis to allow patients to leave the hospital and continue treatment with a potent fungicidal therapy,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Through our collaborative dialogue with the FDA, we have agreed to an innovative study design that provides an expeditious path to gain regulatory approval of ibrexafungerp for a hospital-based indication.” The global Phase 3 multi-center, prospective, randomized, double-blind study of two treatment regimens will evaluate oral ibrexafungerp as a step-down treatment in patients suffering from invasive candidiasis (IC) compared to oral fluconazole. Eligible hospital patients with IC will receive treatment with IV echinocandin and will then be switched to either oral ibrexafungerp or oral fluconazole once step-down criteria are met. Approximately 220 patients will be enrolled and randomized in the study. The primary objective of the study is to determine whether treatment of IC with IV echinocandins followed by o...