SCYNEXIS Announces Positive Results from Pivotal Phase 3 CANDLE Study
Oral ibrexafungerp, a fungicidal oral treatment to prevent recurrent vaginal yeast infections, achieved superiority over the placebo for the primary and key secondary study endpoints.
Scynexis has announced positive results from its global Phase 3 CANDLE study investigating the efficacy and safety of oral ibrexafungerp (Brexafemme) for the prevention of recurrent vulvovaginal candidiasis (VVC), or yeast infection, a condition that causes a considerable amount of discomfort for patients, defined as 3 or more episodes of VVC in the previous 12 months.
There is no approved treatment for the condition.
Approximately 70% to 75% of women worldwide will have at least 1 episode of VVC, and it is estimated that 6% 8% of those women suffer from recurrent disease.
Ibrexafungerp achieved statistically significant superiority over the placebo for efficacy as measured by the percentage of subjects with a clinical success at test-of-cure rate, Scynexis said in a statement.
The study results show that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed or suspected through week 24.
The company plans to submit a supplemental new drug application to the FDA for Brexafemme for the prevention of recurrent VVC in the first half of 2022, with anticipated approval by the end of 2022.
Ibrexafungerp is the only oral fungicidal agent to successfully complete pivotal trials in both the acute treatment and prevention of yeast infections, Scynexis said.
"Ibrexafungerp is the only oral fungicidal agent to successfully complete pivotal trials in both the acute treatment and prevention of yeast infections. As the only non-azole, we believe ibrexafungerp is changing how yeast infections are treated," Marco Taglietti, MD, president and CEO of Scynexis, said in a statement.
"These important results support an additional indication for ibrexafungerp for the prevention of [recurrent] VVC. This exciting achievement is another step in our efforts to bring to market meaningful and innovative solutions in the fight against a broad range of fungal infections and enhance shareholder value,” Taglietti said.
The trial was conducted under a special protocol assessment, a process in which sponsors work with the FDA to reach agreement on the design and size of a clinical trial to adequately address regulatory and scientific requirements for a study that could support marketing approval.
The phase 3 CANDLE study evaluated the efficacy and safety of ibrexafungerp compared with the placebo in 260 female individuals with recurrent VVC.
All individuals initially received a 3-day regimen of fluconazole, and responders were randomized to receive either 300 mg of ibrexafungerp twice a day or the matching placebo once a day for a month for 6 months.
The advantage of ibrexafungerp compared with the placebo was sustained over the 3-month follow-up period and remained statistically significant.
The secondary endpoints were consistent with the results of the primary analysis and will be presented at a future medical meeting.
The study also evaluated an additional group of 24 individuals who failed to respond to the initial 3-day regimen of fluconazole and received a 1-day open-label treatment course of ibrexafungerp at the 300-mg strength taken twice a day. About 71% of individuals treated with ibrexafungerp successfully achieved a significant elimination or reduction of signs and symptoms.
Study results show that ibrexafungerp was generally safe and well-tolerated, with no serious drug-related adverse events (AEs). Additionally, no individual treated with ibrexafungerp discontinued therapy because of AEs.
The most common AEs were gastrointestinal events and headaches, which were mostly mild and generally consistent with the safety profile of ibrexafungerp.
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. LifeSci. News release. February 10, 2022. Accessed February 14, 2022. Email.