SCYNEXIS, Inc., a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced positive results from the first interim efficacy analysis of the ongoing FURI study.
FURI is a Phase 3 open-label study 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 currently available standards of care. An independent expert panel (Data Review Committee) assessed the efficacy of ibrexafungerp in the first 20 treated patients. Oral ibrexafungerp showed clinical benefits in 17 out of 20 patients, with 11 patients achieving a complete or partial response and six patients a stable disease response. Only two patients did not respond to ibrexafungerp treatment and the outcome for one patient was considered indeterminate. Along with demonstrating the ability to treat fungal infections in vulnerable patients who failed other therapies, these preliminary results support continued patient enrollment in the FURI study to build toward a future New Drug Application (NDA) submission and potential approval through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
"The positive results of this first interim analysis met all of our goals," said Dr. Marco Taglietti, Chief Executive Officer of SCYNEXIS. "First, we fulfilled our ethical responsibility to justify the testing of oral ibrexafungerp in this patient population. Second, we showed that ibrexafungerp, administered orally, is effective in treating mucocutaneous and invasive fungal infections that do not respond to other therapies, including those administered intravenously. Third, we generated further evidence validating our vision of ibrexafungerp as a transformative antifungal agent able to address significant unmet needs in both outpatient and hospital settings in a variety of indications."
The 20 patients evaluated in this interim analysis suffered from a variety of severe conditions, including esophageal candidiasis, intra-abdominal abscesses, and oropharyngeal candidiasis, with the most common fungal species being Candida glabrata and Candida krusei, two highly resistant organisms. Ibrexafungerp treatment ranged from seven to 90 days, with a mean duration of 36.4 days.
Oral ibrexafungerp was well-tolerated, with the most common treatment-related adverse events being gastrointestinal. There were no deaths due to progressive fungal disease and no safety signals warranting changes in the study.
"These preliminary results of oral ibrexafungerp in this salvage therapy setting are very promising," said Professor Oliver Cornely, M.D., Director of Clinical Trials Centre University of Cologne, Germany. "At my center, we have enrolled five patients in the FURI study, and I am thrilled that the positive responses observed in our patients are consistent with those observed by other investigators. Having an alternative new treatment to add to our current, limited armamentarium of antifungals, especially an oral option, is critical for those patients with resistant, difficult-to-treat or refractory fungal infections. Additionally, an oral option provides the flexibility and convenience of outpatient maintenance treatment. I am glad to see the progress in the development of oral ibrexafungerp and am looking forward to continuing my contribution to the program."
"The positive results of this interim analysis reassure us of oral ibrexafungerp's clinical benefits in this difficult-to-treat patient population, warranting continued enrollment in the FURI study," said Dr. David Angulo, Chief Medical Officer of SCYNEXIS. "As a physician, it was very gratifying to see patients with no adequate options respond to ibrexafungerp. Many of the patients enrolled in the FURI study are complex clinical cases with multiple underlying medical conditions, such as the following two cases:
A 71-year-old male presented with a perforated duodenal ulcer and a retroperitoneal abscess showing positive culture for C. krusei, a notoriously difficult-to-treat and often multidrug-resistant fungal pathogen. After 19 days of unsuccessful intravenous therapy with an echinocandin (micafungin), the patient was enrolled in the FURI study. Treatment with oral ibrexafungerp for 17 days fully resolved the infection.
A 63-year-old male with a 10-year history of painful esophageal constriction and recurrent esophageal candidiasis required a percutaneous gastroenterostomy feeding tube due to the inability of the patient to swallow and eat. Multiple courses of antifungals were unsuccessful in treating this fluconazole-resistant C. glabrata infection, and the patient was enrolled in the FURI study with severe esophagitis at baseline. After 54 days of oral ibrexafungerp treatment, the infection fully resolved. The patient remained asymptomatic during the follow-up period and the feeding tube was able to be removed.
"On behalf of SCYNEXIS," continued Dr. Angulo, "I would like to thank the patients and investigators for their participation in the FURI study and the independent Data Review Committee for assessing this first group of 20 patients."
SCYNEXIS plans to provide additional details and patient cases of this interim analysis at an upcoming scientific meeting.