The Scynexis ibrexafungerp (Brexafemme) therapy cleared signs and symptoms of vaginal yeast infection in 73.9% of patients.
Today, Scynexis announced the publication of its phase 3 VANISH-306 study in the International Journal of Obstetrics and Gynecology (BJOG). The results show that oral ibrexafungerp safely and effectively treats vulvovaginal candidiasis (VVC; vaginal yeast infection) as compared to placebo.
Patients who received a 1-day treatment with oral ibrexafungerp had significantly higher rates of clinical cure, mycological eradication, and clinical improvement than patients who received placebo.
At day 25, 73.9% of patents treated with ibrexafungerp achieved complete clearing of signs and symptoms.
David Angulo, MD, chief medical officer of Scynexis,said, “Ibrexafungerp is a first-in-class, 1-day oral therapy that blocks glucan synthase, an enzyme critical for the maintenance of the fungal cell wall, and has shown in vitro fungicidal activity against multiple different Candidaspecies strains, including those that are echinocandin and azole resistant.”
VANISH-306 was a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate oral ibrexafungerp in women 12 and older with VVC. At the test-of-cure (TOC) day 10 visit, patients who received ibrexafungerp had statistically significant rates of clinical cure, as compared to the placebo group (63.3% [119/188] vs. 44.0% [37/84]). “Clinical cure” was defined as complete resolution of vulvovaginal signs and symptoms, without further need for antifungal treatment or topical drugs before or at the day 10 TOC visit. The TOC visit also showed higher rates for ibrexafungerp than placebo for mycological eradication (58.5% [110/188] vs. 29.8% [25/84]) and clinical improvement (72.3% [136/188] vs. 54.8% [46/84]).
Ibrexafungerp demonstrated statistical superiority over placebo in the primary endpoint and in vital secondary endpoints. It was generally well tolerated, with the majority of reported adverse events primarily gastrointestinal and mild-to-moderate.
The successful phase 3 VANISH clinical trials (VANISH-303 and VANISH-306) led the US Food and Drug Administration (FDA) to approve Brexafemme ibrexafungerp tablets in June of 2021.
Brexafemme is a triterpenoid antifungal intended to treat adult and postmenarchal pediatric women with VVC. The recommended dose of Brexafemme is 2 150 mg ibrexafungerp tablets twice a day for one day (total treatment dosage of 600 mg).
“We believe the publication of findings from our VANISH-306 study will provide clinicians with valuable knowledge regarding the efficacy and safety of this groundbreaking treatment as a potent therapeutic option for possibly millions of women across the country,” Angulo said.