Therapy Areas: Vaccines
YS Biopharma's Phase three clinical trial of new PIKA Rabies Vaccine reveals positive interim results
10 April 2024 -

YS Biopharma Co, Ltd (Nasdaq: YS), a China-based global biopharmaceutical company, announced on Tuesday positive interim results from the ongoing Phase three clinical trial (the 'Phase 3 Trial' or the 'Trial') of its next-generation PIKA Rabies Vaccine.

According to the company, the interim outcome indicated that the PIKA Rabies Vaccine has successfully met the Trial's primary endpoints. The product has the potential to achieve best-in-class accelerated protection and meet the WHO's aim of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens.

The PIKA Rabies Vaccine is designed to produce a more robust immune response in an accelerated period compared to present rabies vaccines. It received orphan drug designation for the US FDA for prevention of rabies virus infection including post-exposure prophylaxis (PEP) for rabies.

Pivotal registration Phase three Trial, a randomised, comparator-controlled, double-blind, multicentre trial, includes 4,500 participants from the Philippines and Pakistan. It is aimed at assessing the immunogenicity, safety, and lot-to-lot consistency of three lots of the PIKA Rabies Vaccine in healthy adults utilising a seven-day vaccine schedule, compared to a globally marketed comparator after the standard 28-day regimen.