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New possibilities in women’s health
JERSEY CITY, N.J.—Last month, SCYNEXIS Inc. announced that patient enrollment in the VANISH-306 global Phase 3 trial was completed four months ahead of schedule. This study will 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 is a broad-spectrum intravenous/oral antifungal. It is notable not only for being the first in its class, but also the first new antifungal class in over two decades. Ibrexafungerp is currently in late-stage development for a variety of uses, ranging from the treatment and prevention of vaginal yeast infections to the treatment of life-threatening fungal infections in hospitalized patients.
The study is a part of the VANISH program, which is composed of two Phase 3, randomized, double-blind, placebo-controlled, multicenter studies designed to demonstrate superiority of oral ibrexafungerp vs. placebo. There are 455 participants from the United States and Europe enrolled in the VANISH-360 study. Participants have been randomized in a 2:1 ratio to a treatment of either ibrexafungerp or matching placebo. The primary endpoint of the study is the percentage of subjects achieving a clinical cure at the test of cure visit. Secondary endpoints include mycological eradication and change in symptom and severity scores compared to baseline at both day 10 and at the follow-up on day 25. VANISH- 360’s sister study, VANISH- 303, was conducted in U.S. centers only.
“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 Dr. Marco Taglietti, president and CEO 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.”
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.”
VVC is the second most common vaginitis, with strains resistant to the only current treatment—fluconazole—becoming more common. VVC can be associated with substantial morbidity, including significant genital discomfort, reduced sexual pleasure, psychological distress and loss of productivity. Common symptoms include pruritus, vaginal soreness, irritation, excoriation of vaginal mucosa and abnormal vaginal discharge. It is estimated that 70-75 percent of women worldwide have had a VVC episode at least once in their lifetime, and 40-50 percent of them will have more than one. Approximately 6-8 percent of women with VVC suffer from recurrent disease, defined as experiencing at least three episodes within a 12-month period.
Current treatments for VVC include several topical azole antifungals (clotrimazole, miconazole and others) and fluconazole, which reports a 55-percent cure rate on its label—a label which now also includes warnings of potential for fetal harm, illustrating the need for new oral alternatives. The needs of women experiencing moderate to severe fluconazole- or topical-resistant strains of VVC has yet to be addressed. In addition, there are no oral alternatives for VVC patients who do not respond to or do not tolerate fluconazole, and there are no FDA-approved products for the prevention of recurrent VVC.
Ibrexafungerp is an investigational antifungal agent, and is the first representative of a novel class of structurally distinct glucan synthase inhibitors, triterpenoids, which combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Currently in development for the treatment of fungal infections caused primarily by Aspergillus and Candida, which causes VVC, ibrexafungerp has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.
The U.S. Food Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC, and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp was formerly known as SCY-078. SCYNEXIS anticipates top-line data for the VANISH-306 study early in the second quarter of 2020, and plans to submit a New Drug Application to the FDA for the treatment of VVC in the second half of 2020 based on the results from the VANISH program.
SCYNEXIS, Inc. is a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections. The company has extensive experience in the life-sciences industry, having discovered and developed more than 30 medicines over a broad range of therapeutic areas.