Chinese Biotech YS Biopharma's Next-Gen Rabies Vaccine Non-Inferior To Approved Competitor

Tuesday, YS Biopharma Co Ltd YS revealed interim results from the ongoing Phase 3 clinical trial of its next-generation PIKA Rabies Vaccine. 

The interim results indicate that the PIKA Rabies Vaccine has successfully met the primary endpoints and can potentially meet the WHO’s goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens.

The PIKA Rabies Vaccine, which utilizes YS Biopharma’s proprietary PIKA adjuvant technology, is designed to produce a more robust immune response in an accelerated timespan than existing rabies vaccines. 

The FDA granted it orphan drug designation for prevention of rabies virus infection, including post-exposure prophylaxis for rabies.

The Phase 3 trial, which includes 4,500 participants, is designed to assess the immunogenicity, safety, and lot-to-lot consistency of three lots of the PIKA Rabies Vaccine in healthy adults using a 7-day vaccine schedule versus a globally marketed comparator following the standard 28-day regimen. 

The study’s primary immunogenicity endpoints were the geometric mean titers (GMTs) of rabies virus neutralizing antibodies (RVNA) and the RVNA seroconversion rate at Day 14 in the first 900 participants. 

The secondary immunogenicity endpoints were RVNA seroconversion rate and GMTs of RVNA at Day 28, Day 42, Day 90, and Day 180 in the first 900 participants and RVNA seroconversion rate at Day 7 and Day 365 in all participants.

Based on the interim data analysis, the PIKA Rabies Vaccine demonstrates non-inferior immunogenicity to a globally marketed comparator while helping patients achieve immunity in a shorter timeframe of 7 days. 

The data, which comes from the first 900 participants enrolled in the trial, revealed that the RVNA seroconversion rate of the PIKA Rabies Vaccine was twice that of the comparator by Day 7, showing the superiority of the PIKA rabies vaccine in offering a quick onset of protection against virus infection. 

“At present, the long and inconvenient regimen length for existing rabies vaccines represents a major barrier to treatment completion, and we are eager to see how the enhanced speed of the PIKA rabies vaccine might have a positive impact on patients,” Zenaida Mojares, Chief Medical Officer said. “We are proud of our team for the hard work and dedication which got us to this point, and we are excited to see how our advances will contribute to the ongoing global fight against rabies.”

Price Action: YS shares are down 2.27% at $0.86 on the last check Tuesday.

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