SCYNEXIS, Inc. announced on May 28, 2025, that patient dosing has resumed in the Phase 3 MARIO study for oral ibrexafungerp. This study investigates ibrexafungerp as a step-down antifungal therapy for invasive candidiasis, a life-threatening infection.
The study had been on a clinical hold for 19 months due to concerns about potential cross-contamination at a manufacturing site, but the hold was lifted by the FDA in April 2025 following the manufacture of new clinical supplies at another site. The rapid resumption of patient enrollment reflects the scientific community's eagerness for new treatment options.
SCYNEXIS's position is that the dosing of this first new patient triggers a $10 million payment from its partner GSK, with an additional $20 million payment expected at the six-month anniversary of dosing. However, a disagreement between SCYNEXIS and GSK regarding these milestone payments is ongoing.
If successful, the MARIO study could provide healthcare providers with a non-azole oral option that retains the glucan synthase inhibition mechanism, which is the gold standard for IV echinocandins. This represents a significant advancement for patients with invasive Candida infections.
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