Barinthus Biotherapeutics plc announced topline final data from the APOLLO trial (also known as HPV001), a completed randomized, placebo-controlled Phase 1b/2 dose-ranging trial of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection. APOLLO (NCT04607850) was a randomized, placebo-controlled Phase 1b/2 multi-center trial of 108 participants across the UK and EU evaluating the safety, tolerability and immunogenicity of VTP-200 in women aged 25-55 with persistent hrHPV infection and low-grade cervical lesions. The primary objective was to evaluate the safety and tolerability of VTP-200.

The trial was also designed to assess the effect of VTP-200 on clearance of hrHPV infection and cervical lesion(s), as well as select appropriate doses for further development. The APOLLO study met its primary safety endpoint, demonstrating that VTP-200 was generally well-tolerated and was administered with no treatment-related grade 3 or higher unsolicited AEs and no treatment-related SAEs. The hrHPV clearance rate of 60% at Month 12 was observed in group 2, which included the dose of ChAdOx, compared to a 33% clearance rate in the placebo group.

Groups 1, 3, 4 and 5 showed 12%, 11%, 33% and 36% hrHPV clearance rates, respectively. The study also evaluated cervical lesion clearance rates in participants with both reported lesions at screening and visualization of the cervical transformation zone at 12 months (n=57). The cervical lesion clearance rate of 67% was observed in group 2 and group 5, both received the dose of ChAdOx, compared to 39% in the placebo group.

Groups 1, 3 and 4 showed 40%, 20% and 33% cervical lesion clearance rates, respectively. Pooled data from the five active dose groups showed no significant improvement in hrHPV clearance or cervical lesion clearance rates in comparison to the placebo group. Future development options for the VTP-200 program are currently being evaluated with further analyses ongoing.