Scynexis Announces Results From Phase 3 Trial for Ibrexafungerp
The VANISH-303 and VANISH-306 studies provide analysis of tablets that treat vulvovaginal candidiasis, which is vaginal yeast infection.
Scynexis Inc has announced the peer-reviewed publication of results from its phase 3 VANISH-306 studies for ibrexafungerp (Brexafemme) in the International Journal of Obstetrics and Gynaecology.
“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 Candida species strains, including those that are echinocandin and azole resistant,” David Angulo, MD, chief medical officer of Scynexis, said in a statement.
The VANISH program included 2 phase 3 studies, VANISH-303 and VANISH-306, for ibrexafungerp tablets for the treatment of vulvovaginal candidiasis, known as a vaginal yeast infection.
The study results show that the treatment of ibrexafungerp achieved superiority over a placebo with a high degree of statistical significance on key study endpoints and was generally safe and well-tolerated.
At the test of cure (TOC) day 10 visit, individuals receiving ibrexafungerp had a 63.3% clinical cure rate compared with the placebo at 44%, which was defined as complete resolution without the need for further antifungal treatment or topical drug therapy before or at the TOC visit.
The day 10 results also show higher rates in mycological eradication at 58% compared with the placebo at 29.8% and clinical improvement at 72.3% compared with the placebo at 54.8%.
Adverse events were reported to be primarily gastrointestinal and were mild to moderate in severity.
At the day 25 visit, symptom resolution was sustained and increased to 73.9% compared with 52.4% for the placebo.
Significant results for individuals with Candida albicans, at baseline, with complete resolution of 77% compared with the placebo at 52.6%.
SCYNEXIS Pivotal Phase 3 VANISH-306 trial results Published in the International Journal of Obstetrics and Gynaecology (BJOG) demonstrate statistical superiority of BREXAFEMME® (Ibrexafungerp Tablets) over placebo for vaginal yeast infection. News release. November 23, 2021. Accessed November 23, 2021. Email.