Mycovia’s VIVJOA Shows Sustained 96-Week Protection Against Recurrent Yeast Infections

Mycovia Pharmaceuticals has published new long-term results showing that VIVJOA® (oteseconazole) continues to protect women against recurrent vulvovaginal candidiasis (RVVC) for nearly two years. The data come from the extension phase of the VIOLET Phase 3 program and appear in the Journal of Women’s Health.

VIVJOA is the first and only FDA-approved therapy for RVVC, indicated for post-menopausal women or women not of reproductive potential.

Phase 3 Findings (Original VIOLET Trials)

The VIOLET trials were two global, double-blind, placebo-controlled studies that supported FDA approval in 2022.
Key results:

• Up to 96% of women taking VIVJOA remained infection-free through 48 weeks.
• 61% remained infection-free on placebo.
• P < 0.001, demonstrating statistical superiority.
• Safety profile was comparable to placebo; most common AEs:
  - Headache (7.4%)
  - Nausea (3.6%)

Long-Term Extension Study (New Data)

Women who had no RVVC episodes during the initial 48 weeks were followed for an additional 48 weeks, bringing total observation to 96 weeks.

• 98% of women originally randomized to VIVJOA remained infection-free through 96 weeks.
• 82% of women originally receiving placebo remained infection-free.
• Result indicates sustained protection for nearly two years after treatment.

Expert Commentary

Investigators highlighted that VIVJOA offers:

• A shorter dosing regimen
• Better long-term outcomes compared with fluconazole
• A meaningful option for women experiencing multiple infections annually (some > 20 episodes pre-study)

Mycovia executives noted that RVVC is often overlooked despite being chronic, painful, and linked to major quality-of-life and emotional burdens.

About RVVC

• Affects 138 million women globally each year.
• Defined as ≥3 symptomatic acute VVC episodes in 12 months.
• Symptoms include itching, burning, inflammation, painful intercourse, and abnormal discharge.
• Causes significant physical, emotional, and economic burden.

About VIVJOA® (oteseconazole)

VIVJOA is an azole antifungal designed to selectively inhibit fungal CYP51, sparing human enzymes and reducing fungal cell growth.

Approved based on three Phase 3 trials:

• VIOLET 1 & 2
• ultraVIOLET (US study)
  Total: 875 patients across 232 sites in 11 countries

Safety and Contraindications

VIVJOA is contraindicated in:

• Females of reproductive potential
• Pregnant or lactating women
• Patients with hypersensitivity to oteseconazole

Warnings include potential fetal harm due to long drug-elimination duration.

Common adverse reactions:

• Headache (7.4%)
• Nausea (3.6%)

Drug interaction caution:

• BCRP inhibitor → may increase exposure to drugs like rosuvastatin.

About Mycovia

Mycovia focuses on therapies for unmet infectious-disease needs.
VIVJOA is its first FDA-approved therapy. The company is also developing oral fungal inhibitors targeting multi-drug-resistant pathogens.

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