Business
SCYNEXIS Announces Positive Results from Interim Analyses of Ongoing Phase 3 Studies (FURI and CARES), Demonstrating Oral Ibrexafungerp's Ability to Treat Severe Fungal Infections in the Hospital Setting
Consistent with prior two interim analyses, FURI results confirm positive clinical activity of oral ibrexafungerp in patients with difficult-to-treat, severe,
About this update from Scynexis, Inc.
[{"type":"text","content":"Consistent with prior two interim analyses, FURI results confirm positive clinical activity of oral ibrexafungerp in patients with difficult-to-treat, severe, mucocutaneous and invasive fungal infections, including those caused by resistant strains1st Interim analysis of CARES study shows strong clinical activity of oral ibrexafungerp in patients with Candida auris, a high-mortality infection classified by CDC as an Urgent Threat to public healthResults support continued enrollment in both studies, with potential future submissions under the LPAD regulatory pathwayConference call to be held March 2nd, 2021 at 8:30 a.m. ET JERSEY CITY, N.J., March 02, 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 positive results from the third interim efficacy analysis of the ongoing open-label Phase 3 FURI study and the first interim analysis of the ongoing open-label Phase 3 CARES study. The global, open-label Phase 3 FURI study is designed to evaluate oral ibrexafungerp as a salvage treatment for 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-down therapy for the treatment of azole-resistant species. The global, open-label Phase 3 CARES study is focused on hospitalized patients with invasive candidiasis caused by the emerging Candida auris, an organism that is often multi-drug resistant, associated with high mortality and classified by the Centers for Disease Control and Prevention (CDC) as an Urgent Threat to public health. Furthermore, Candida auris has been shown to easily spread through contact in healthcare facilities, causing difficult-to-control outbreaks. Increased C. auris cases globally have been associated with higher rates of hospitalization due to the COVID pandemic. Each study is intended to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). A Data Review Committee (DRC) of independent experts assessed the efficacy of oral ibrexafungerp in a third cohort of 33 patients from the FURI study and 10 patients from the CARES study. The third interim analysis of the F...