Antiva Biosciences has announced positive results from its Phase 1b/2 trial of ABI-2280, a topical treatment for high-risk HPV cervical infections. The study met its primary endpoint, with 46% of patients achieving HPV negativity at 12 weeks compared to 16% in the placebo group.
The trial evaluated ABI-2280 in 139 women aged 25-55 with persistent cervical high-risk HPV infections. The most effective regimen involved 1mg doses administered three times over two weeks, showing a 30 percentage point improvement over placebo in HPV negativity rates.
Durability data showed 87% of patients who achieved HPV negativity at week 12 maintained negative status at week 24. The treatment demonstrated clear separation from placebo at all timepoints throughout the study.
“Women with persistent high-risk HPV have an approximately one-in-five chance of their infection progressing to pre-cancer or worse over four-to-six years, yet they do not have any options to treat the infection,” said Professor Margaret Stanley of the University of Cambridge.
ABI-2280 demonstrated favorable safety, with most adverse events categorized as mild to moderate and localized to the treatment area. The treatment works by blocking HPV replication and inducing cell death in HPV-infected cells.
The trial addresses significant unmet need, as over 6 million U.S. women become newly infected with high-risk HPV annually. No approved therapeutic options currently exist, leaving patients in a “wait and see” approach until infections clear naturally or progress to precancerous conditions.
Approximately 30% of women with high-risk HPV fail to clear the virus within 12 months, affecting an estimated 19 million U.S. women of reproductive age. Antiva plans to advance to Phase 2b trials based on these results.
