Promising Phase 3 Data Suggest Efficacy of Ibrexafungerp for Vaginal Yeast Infection

Recent trial data, published in the Journal of Women’s Health, suggested the promise of ibrexafungerp for treating vulvovaginal candidiasis, or yeast infection.

Ibrexafungerp is a novel oral antifungal developed by the biotechnology company Scynexis, Inc.

To understand the significance of these trial results, and the need for new yeast infection treatments, Contagion interviewed Tosin Jaiyeoba Goje, MD, MSCR, FACOG. Goje is the medical director of the Cleveland Clinic Center for Infant and Maternal Health, as well as an associate professor, of ob-gyn and reproductive biology at the Cleveland Clinic Lerner College of Medicine.

Goje emphasized that yeast infections can be severely detrimental to patients’ everyday life. She specifically noted the psychosocial, sexual, and financial impacts of yeast infection. “Overall it just affects their quality of life,” said Goje, “and I think the quality of life of a person is important.”

Goje said there is a significant lack of medications for women’s health, especially when compared to other specialties.

These positive data for ibrexafungerp resulted from 2 different stage 3 clinical trials. Pooled analysis from these randomized, double-blind, multicenter, placebo-controlled studies found that the patients receiving ibrexafungerp had significantly higher rates of clinical improvement, complete symptom resolution, and mycological cure.

The study patients ranged from 12-80 years in age, and represented a variety of race, ethnicity, and body mass index (BMI). Participants were excluded if they had an otherwise immunocompromised state.

Ibrexafungerp was found to be safe and tolerable, and most reported side effects were gastrointestinal.

“It’s important that race did not impact the drug,” Goje said. “Everyone from all race and ethnicity can benefit from the drug. Additionally, “The BMI did not have any negative impact.”

Circling back to her point that vaginal candidiasis affects quality of life, Goje concluded, “We want to have medications that are not just effective, but for all people.”