Phase 3 Study: VIVJOA® (Oteseconazole) Efficacy and Safety in Severe VVC

Mycvia Pharmaceuticals, a biopharmaceutical firm, has reported on a phase 3 study comparing VIVJOA® (oteseconazole) with fluconazole for severe vulvovaginal candidiasis (VVC) in Chinese women. The study, published in Antimicrobial Agents and Chemotherapy, was a randomized, double-blinded multi-center trial. VIVJOA showed superiority over fluconazole, with a higher percentage of therapeutic cure at Day 28. The rates of treatment-emergent adverse events were similar between the two treatment groups.

The study's authors found that VIVJOA was statistically more effective in treating severe VVC compared to fluconazole. At Day 28, a higher percentage of patients treated with VIVJOA achieved therapeutic cure, with no signs or symptoms of VVC and negative Candida culture. Mycological and clinical cure rates were also higher for VIVJOA-treated patients. At Day 14, VIVJOA continued to show superiority in therapeutic and mycological cure rates.

The rates of patients experiencing at least one treatment-emergent adverse event (TEAE) were comparable between the two groups. Similar rates of treatment-related adverse events were reported, with urinary tract infection and bacterial vulvovaginitis being the most commonly reported TEAEs.

Stephen Brand, Chief Development Officer at Mycovia, highlighted the significance of the study as the first head-to-head comparison of VIVJOA and fluconazole, which has been the standard treatment for VVC for over 30 years. VIVJOA's approval in China offers a new, safe, and effective oral treatment option for healthcare providers and patients.

Vulvovaginal candidiasis is a common infection usually caused by Candida albicans, with symptoms including itching, irritation, and vaginal discharge. Oteseconazole, the active ingredient in VIVJOA, selectively inhibits fungal CYP51, which is necessary for fungal cell wall integrity, and has a lower affinity for human CYP enzymes than for fungal ones.

The FDA approved VIVJOA in April 2022 for Recurrent Vulvovaginal Candidiasis, and it received approval in China in June 2023 for the treatment of severe VVC. VIVJOA is indicated to reduce the recurrence of vulvovaginal candidiasis in females not of reproductive potential.

VIVJOA is contraindicated in females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to oteseconazole. It may cause fetal harm, and its use is not recommended for these groups due to the potential risks. The most frequently reported adverse reactions in clinical studies were headache and nausea. VIVJOA is also a Breast Cancer Resistance Protein (BCRP) inhibitor, which may increase the exposure of BCRP substrates and the risk of adverse reactions when used concomitantly.

Mycovia Pharmaceuticals is dedicated to developing novel therapies for unmet medical needs, and VIVJOA is their first FDA-approved product. Jiangsu Hengrui Pharmaceuticals, Mycovia's partner, is a leading global pharmaceutical company focused on innovation and quality healthcare products.