Oral ibrexafungerp exhibits positive outcomes in patients with recurrent vulvovaginal candidiasis
Oral ibrexafungerp had positive outcomes in patients with recurrent vulvovaginal candidiasis who had failed fluconazole treatment, according to the CANDLE 304s nested sub-study.
The results were presented during the International Society for the Study of Vulvovaginal Diseases (ISSVD) XXVI World Congress and International Vulvovaginal Disease Update 2022 held in Dublin, Ireland, July 15-20, 2022.
"We are thrilled to present these data demonstrating positive outcomes in RVVC patients who failed fluconazole therapy for an acute VVC episode," said Nkechi Azie, M.D., Vice President, Clinical Development and Medical Affairs at SCYNEXIS.
"The response to ibrexafungerp in this clinically challenging population is extremely encouraging and further demonstrates the potential efficacy of ibrexafungerp to treat recurrent yeast infections in patients with limited treatment options. We hope to expand upon these data with the recently announced Phase 3b VANQUISH study."
The CANDLE open-label sub-study enrolled 24 patients who failed to respond to an initial three-doses of fluconazole given over seven days. Fluconazole failure was defined as persistent vaginal signs and symptoms (VSS) score equal to or greater than three after therapy. Participants received a one-day treatment of ibrexafungerp (300 mg BID). In this population, 71% of patients (17 of 24) achieved a significant reduction or elimination of signs and symptoms after treatment with ibrexafungerp.
This positive trend was also confirmed in the subset of subjects who in addition to having a clinical failure also had persistent positive cultures after fluconazole treatment (microbiological failure). Favorable clinical response after a single day of ibrexafungerp was reported in eight of 10 subjects (80%) in this sub-group.
SCYNEXIS plans to present CANDLE main results next month during the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston, August 4-6, 2022.
In addition, SCYNEXIS recently announced the first patient enrolled in its Phase 3b, open-label, multicenter VANQUISH study to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a treatment for complicated vulvovaginal candidiasis (VVC) in patients who have failed treatment with fluconazole, based on mycological and clinical outcomes. Complicated patients include patients with recurrent VVC, those with VVC caused by non-albicans Candida species and those with diabetes, immunocompromising conditions (e.g., HIV), or immunosuppressive therapy (e.g., corticosteroids).
In June, SCYNEXIS submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for an additional indication for BREXAFEMME® (ibrexafungerp tablets) for the prevention of RVVC. The submission was based on positive results from the CANDLE study, which showed that ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.
