Positive results were announced from a phase 3 study evaluating ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (rVVC).

Ibrexafungerp is an oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids. The multicenter, randomized, double-blind, placebo-controlled CANDLE study (ClinicalTrials.gov Identifier: NCT04029116) compared the efficacy and safety of ibrexafungerp to placebo in 260 female patients 12 years of age and older with rVVC, defined as 3 or more episodes of VVC in the previous 12 months. 

All patients received an initial 3-day regimen of oral fluconazole to treat their acute episode present at screening. Responders were randomly assigned to receive either ibrexafungerp or placebo once per month for a total of 6 months. Efficacy was measured by the percentage of patients with clinical success, defined as patients having no culture-proven, presumed or suspected recurrences of VVC through the test-of-cure evaluation at week 24.

Findings showed that a greater proportion of patients treated with ibrexafungerp achieved clinical success with no recurrence of VVC at all through week 24 compared with placebo (65.4% vs 53.1%, respectively; P =.02); these results were sustained over a 3-month follow-up period (P =.034). Secondary endpoints were also consistent with the results of the primary analysis; additional analysis is expected at a future medical meeting.

Among the 24 patients who failed to respond to the initial 3-day regimen of fluconazole and received a 1-day regimen of ibrexafungerp, findings showed that 71% achieved a significant reduction or complete elimination of signs and symptoms.

Ibrexafungerp was found to be generally safe and well tolerated with the most common adverse events being headache and gastrointestinal events, which were mild. There were no serious drug-related adverse events reported.

“After developing ibrexafungerp as the first approved oral non-azole agent to treat VVC, this study shows that it also prevents recurrences of the disease, as well as helps patients who failed to respond to multiple doses of fluconazole,” said David Angulo, MD, Chief Medical Officer of Scynexis. “We are excited to see these important results that further demonstrate the unmatched abilities of ibrexafungerp as a powerful oral antifungal therapy with potential broad utility against fungal infections.”

Ibrexafungerp is currently marketed under the brand name Brexafemme and is approved for the treatment of VVC in adult and postmenarchal pediatric females. The Company plans to submit a supplemental New Drug Application for the prevention of rVVC in the first half of 2022.

Reference

Scynexis announces positive results from its pivotal phase 3 CANDLE study of oral ibrexafungerp for prevention of recurrent vaginal yeast infections, clearing the way for regulatory submission and potential approval of additional indication by end of 2022. News release. Scynexis, Inc. Accessed February 10, 2022. https://www.globenewswire.com/news-release/2022/02/10/2382773/0/en/SCYNEXIS-Announces-Positive-Results-from-Its-Pivotal-Phase-3-CANDLE-Study-of-Oral-Ibrexafungerp-for-Prevention-of-Recurrent-Vaginal-Yeast-Infections-Clearing-the-Way-for-Regulatory.html