YS Biopharma Co., Ltd. announced that it has enrolled the first subject in its Phase 3 clinical trial of the Company's PIKA Rabies Vaccine. The Trial, which will assess the safety, immunogenicity, and lot-to-lot consistency of the PIKA Rabies VaccINE, is expected to include an estimated 4,500 subjects in total. The PIKA Rabies Vaccines, which utilizes YS Biopharma's proprietary PIKA adjuvant technology, is designed to produce a more robust immune response in an accelerated timespan compared to existing rabies vaccines.

Previous Phase 1 and Phase 2 clinical trials of the PIKA Rabie Vaccine have demonstrated its safety and strong immunogenicity, with the PIKA Rabies vaccine eliciting a detectable immune response in as quick as seven days. Given these results, the PIKA Rabies vaccines has the potential to achieve best-in-class accelerated protection and meet the WHO's goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. Immunogenicity and consistency will be assessed using measurements of rabies virus neutralizing antibodies at day 14, while immunologic non-inferiority will be evaluated based on differences in RVNA seroconversion rates between the control vaccine and the PIKA Rabiesvaccine at day 14.