SCYNEXIS, Inc., a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced that it has completed patient enrollment in its global Phase 3 VANISH-306 study to evaluate the safety and efficacy of oral ibrexafungerp as a treatment for women with vulvovaginal candidiasis (VVC), commonly referred to as vaginal yeast infection. Ibrexafungerp, the first agent in a novel therapeutic class, is a broad-spectrum, IV/oral antifungal in late stage development for multiple indications, from the treatment and prevention of vaginal yeast infections to the treatment of life-threatening fungal infections in hospitalized patients.
“Vaginal yeast infections affect up to three out of four women at some point in their lifetimes, yet there is only one oral approved therapy that doesn’t work for everyone, so we are committed to providing women with a novel oral alternative,” said Marco Taglietti, M.D., president and chief executive officer of SCYNEXIS. “With enrollment now completed in this second pivotal Phase 3 trial (VANISH-306), and pending findings consistent with the previously reported positive results from our first Phase 3 study (VANISH-303), we remain on track to submit an NDA to the FDA for the treatment of VVC in the second half of 2020. Similar to the VANISH-303 study, the enrollment in this second study was completed about four months ahead of schedule, underscoring the global need for new vaginal yeast infection treatment options for both women and physicians.”
Dr. Taglietti continued, “While VANISH-303 and VANISH-306 are expected to provide the clinical evidence to support an indication for the treatment of VVC, enrollment continues in our CANDLE study for the prevention of recurrent VVC, with the potential for ibrexafungerp to be the first and only agent approved for both the treatment of vaginal yeast infections and prevention of recurrence. If approved, ibrexafungerp would represent the first new class of antifungals approved in over 20 years.”
The VANISH-306 study enrolled 455 eligible subjects across the U.S. and Europe and randomized in a 2:1 ratio to a one-day treatment of either ibrexafungerp (two doses of 300-mg, 12 hours apart) or matching placebo. The primary endpoint of the study is the percentage of subjects achieving a clinical cure at the test of cure visit. More information about this study can be found at: https://clinicaltrials.
Vulvovaginal Candidiasis (VVC), commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis. Although these infections are frequently caused by Candida albicans, fluconazole-resistant Candida