SCYNEXIS Announces Positive Results from Ibrexafungerp Study

SCYNEXIS announced positive results from its second interim efficacy analysis of the ongoing Phase 3 open-label FURI study. The study is evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to or intolerant of current standards of care, or require a non-azole oral step-down therapy for treatment of azole-resistant Candida species. Ibrexafungerp is the first representative of a novel antifungal family, the 'fungerps', being developed for oral and intravenous (IV) usage to treat multiple serious fungal infections, including ones that have shown resistance or have not responded to existing therapies.

A Data Review Committee (DRC) of independent experts assessed the efficacy of oral ibrexafungerp in a second cohort of 21 treated patients from the FURI study. Together with the initial 20 patients reported in January 2019, the dataset consists of 41 patients analyzed to date. Efficacy was consistent across both interim analyses, as oral ibrexafungerp showed clinical benefits in 83% of patients (34 out 41), with 23 patients achieving a complete or partial response and 11 patients a stable disease response. Of the 41 treated patients, only six did not respond to ibrexafungerp treatment and one patient was considered indeterminate.

These positive results support the continued patient enrollment in the FURI study and build toward a future New Drug Application (NDA) submission and potential approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).

"These interim results, combined with the positive Phase 3 data from our vulvovaginal candidiasis (VVC) program, confirm the potential for ibrexafungerp to be a transformative antifungal agent across a variety of indications, addressing needs in both the in-patient and out-patient markets," said Marco Taglietti, MD., President and Chief Executive Officer of SCYNEXIS. "We believe that ibrexafungerp combines the best attributes of existing antifungal classes, such as oral administration, broad spectrum activity including against resistant pathogens, and a favorable safety profile, enabling us to maximize its full potential across several indications to benefit patients in need, physicians who treat them, and the investment community that has supported our programs."

The 41 patients in the aggregate analysis suffered from a variety of severe conditions, including candidemia, intra-abdominal abscesses, esophageal candidiasis, oropharyngeal candidiasis, and bone infections. Candida glabrata and Candida krusei, two highly resistant organisms, were reported in approximately 70% of the cases. Ibrexafungerp treatment ranged from five to 90 days, with a mean duration of 37.1 days.

This second interim analysis was limited to patients who had completed treatment by the end of October 2019, and many patients are still on therapy and have not yet reached the point of clinical assessment. The FURI study protocol was recently amended to also include patients with aspergillosis, coccidioidomycosis, histoplasmosis, blastomycosis and other emerging, difficult-to-treat fungal infections. The maximum allowed treatment duration was also extended from 90 days to up to six months as needed for chronic conditions, based on favorable preclinical toxicology studies.

Oral ibrexafungerp was generally safe and well-tolerated, with gastrointestinal issues cited as the most common treatment-related adverse events. One patient with an ongoing fungal infection died while on study drug due to an underlying condition. The death was considered not drug-related and there were no safety signals warranting changes to the study.

"The positive results from this second interim analysis are fully consistent with the positive outcomes observed in the first interim analysis," said David Angulo, MD., Chief Medical Officer of SCYNEXIS. "Patients enrolled in the FURI study typically suffer from complex underlying medical conditions, aggravated by a severe fungal infection. We are pleased to see many responding favorably to treatment with ibrexafungerp and are optimistic it will be a much-needed alternative for patients suffering from difficult-to-treat, severe fungal infections, particularly given the limited treatment options available and the increase in drug-resistance. We anticipate meeting with the FDA to discuss these preliminary data and our salvage therapy program."

SCYNEXIS plans to provide additional details and patient cases from this interim analysis at an upcoming scientific meeting.

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