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March 15, 2021

LoA Update: Scynexis’ ibrexafungerp sees 3-point increase in US approval potential with positive interim Phase III systemic candidiasis data

Scynexis’ Phase III ibrexafungerp saw a 3-point boost as of 4 March on its FDA likelihood of approval (LoA) in hospitalised systemic candidiasis caused by Candida auris.

By Reynald Castañeda

Scynexis’ Phase III ibrexafungerp saw a 3-point boost as of 4 March on its FDA likelihood of approval (LoA) in hospitalised systemic candidiasis caused by Candida auris. The increase is on the heels of positive interim analysis of the Phase III CARES trial released on 2 March.

Oral ibrexafungerp previously had a 52% LoA, which rose to 55%, according to GlobalData analysis using a combination of machine learning and its proprietary algorithm. Interim CARES data is from the first 10 patients of the 30-patient trial; eight patients with invasive candidiasis and candidemia experienced complete response. The trial has a primary endpoint of global success at end of treatment. Interim data supports continued enrolment of the CARES trial, as per a company media release. CARES is designed to support future NDA submission via the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).

Also, on 2 March, Scynexis reported positive results from a third interim efficacy analysis of the 200-patient Phase III FURI trial of ibrexafungerp as salvage therapy. FURI recruited patients who have mucocutaneous and invasive fungal infections refractory or intolerant to standard of care, or patients who need nonazole step-down therapy against azole-resistant species. In FURI, ibrexafungerp’s clinical benefit currently stands at 87% in the trial’s primary endpoint of global response.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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