Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus‐induced genital lesions

AIMS: To assess safety and tolerability and explore pharmacodynamics and efficacy of omiganan in external anogenital warts (AGW) and vulvar high-grade squamous intraepithelial lesions (HSIL). METHODS: Two randomized controlled trials in patients with external anogenital warts and vulvar HSIL were conducted. Patients received topical omiganan 2.5% or placebo gel once daily for 12 weeks with a follow-up of 12 weeks. Safety and tolerability were monitored and pharmacodynamics and clinical efficacy of omiganan were assessed by analyzing lesion count, size and viral load. Self-reported pain, itch and quality of life were assessed by an electronic diary and questionnaire. RESULTS: Twenty-four AGW and 12 vulvar HSIL patients were enrolled. All patients had a high treatment adherence (99%). No serious adverse events occurred and all adverse events (n=27) were mild, transient and self-limiting. The treatment groups were not different in terms of safety and tolerability, lesion count and size and patient-reported outcomes pain, itch and quality of life. HPV load significantly reduced after 12 weeks of treatment with omiganan compared to placebo (-96.6%; 95% CI -99.9 to - 7.4%; p=0.045) in AGW patients only. CONCLUSIONS: Topical omiganan appears to be safe in patients with AGW and vulvar HSIL and reduced HPV load after 12 weeks of treatment in AGW patients.