Scynexis resumes patient dosing in Phase 3 MARIO study

SCYNEXIS (SCYX) announced that patient dosing has resumed in the Phase 3 MARIO study, which is an innovative study to investigate oral ibrexafungerp as a potential step-down antifungal therapy following IV echinocandin for invasive candidiasis, a life-threatening infection. The study had been on hold due to concerns about potential cross-contamination in light of draft U.S. Food and Drug Administration guidance regarding manufacturing a non-antibiotic beta-lactam at the same site as ibrexafungerp. The study has resumed following the manufacture of new clinical supplies at another site and the lifting of the clinical hold by the FDA. If the study is successful and approval for this indication is granted by the FDA, it will give healthcare providers the opportunity to step-down their patients to a non-azole oral therapy that retains the Mechanism of Action of the IV-only echinocandins, which are the gold standard for treatment of invasive Candida infections. SCYNEXIS’s position is that the dosing of this first new patient triggers a $10 million payment from partner GSK, with another $20 million payment to be triggered by the six-month anniversary of dosing. As previously disclosed, there is a disagreement between SCYNEXIS and GSK regarding the resumption of the MARIO Study and GSK’s (GSK) responsibility for paying these milestones. SCYNEXIS is working to resolve the disagreement.