The company said its investigational therapy, ibrexafungerp, demonstrated superiority to placebo for treatment of vaginal yeast infections, and is working towards its Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) date next month.
In 2020, 9.5 million women in the United States alone were estimated to have received prescriptions for vaginal yeast infections, and about 40% of them required multiple prescriptions, according to Jersey City, New Jersey-based Scynexis.
The company recently reported data from its phase 3 VANISH study for treatment of vulvovaginal candidiasis (VVC) with its investigational treatment, ibrexafungerp, with a 1-day dose of the oral treatment demonstrating superiority to placebo.
The VANISH-306 study evaluated the safety and efficacy of ibrexafungerp as a treatment for patients with VVC (mITT 272 subjects). Severe VVC patients (VSS>7), categorized as complicated patients, accounted for 91.9%% of the patients in the in the study.
Current guidelines recommend that patients with severe symptoms receive a longer course of azole therapy.
The clinical cure rate was defined “as complete resolution of all vaginal signs and symptoms (VSS=0) at the Day-10 test-of-cure visit, reported as 63.3% in the treatment arm versus 44.0% in the placebo arm (p=0.007). Additionally, mycological eradication and clinical improvement, defined as VSS equal to 1 or 0, was seen in 58.5% and 72.3% of patients in the treatment arm, respectively, at the Day-10 test-of-cure visit (p<0.001, p<0.01),” according to a poster presented at the 2021 American College of Obstetricians and Gynecologists Annual Meeting, which took place virtually 2 weeks ago.
The market for antifungals is a mature one and has not seen much in the way of development of new agents and therapies for several years. If FDA approved, this would be the first novel antifungal class in over 20 years and first and only non-azole treatment for vaginal yeast infection.
“Candida albicans has been the prominent species causing vaginal yeast infections, however, we are seeing a notable shift in the etiology candidiasis with non-albicans Candida species gaining prominence,” Scynexis Vice President, Clinical Development and Medical Affairs Nkechi Azie, MD, said. “Fluconazole is not recommended for treatment of non-albicans Candida VVC, often because of a high rate of resistance, leaving no oral treatment options for this difficult-to-treat patient population,”
Scynexis is looking at a potential FDA approval in 2021, and is under regulatory review with a PDUFA target action date set for June 1.
“We believe our oral, fungicidal, non-azole candidate, ibrexafungerp, if approved for the treatment of vaginal yeast infections, may provide a significant benefit for clinicians and patients not satisfied with existing azole-based therapies,” Scynexis President and CEO Marco Taglietti, MD, stated.
Contagion interviewed Taglietti last year about the investigational therapy and its ongoing studies. It can be viewed here.