YS Biopharma Reports Positive Phase 3 Results for PIKA Rabies Vaccine

YS Biopharma, a biopharmaceutical firm specializing in the innovation, production, and delivery of vaccines and biotherapeutics for infectious diseases and cancer, recently reported promising interim results from its ongoing Phase 3 clinical trial of the PIKA Rabies Vaccine. Analysis indicates that the vaccine has met primary trial objectives and shows strong potential for achieving rapid protection standards set by WHO, potentially reducing the typical rabies vaccination schedule from three to four weeks down to just one week.

The PIKA Rabies Vaccine employs YS Biopharma's unique PIKA adjuvant technology, aimed at eliciting a rapid and robust immune response compared to current rabies vaccines. It has received orphan drug status from the FDA for preventing rabies viral infection, including post-exposure treatment.

The pivotal Phase 3 trial, which is randomized, controlled, and double-blind, involves 4,500 participants across the Philippines and Pakistan. It assesses the vaccine's immunogenicity, safety, and consistency. Participants are divided to receive either the PIKA Rabies Vaccine over a 7-day course or a standard vaccine over a 28-day course. The primary measure of success is the geometric mean titers (GMTs) of rabies virus-neutralizing antibodies (RVNA) and the RVNA seroconversion rate at Day 14 among the first 900 participants. Secondary measures include assessing these parameters at various intervals up to a year.

Interim data shows that the PIKA Rabies Vaccine achieves immunity at Day 7 at double the rate of the comparator, underscoring its potential for rapid protection. Additionally, the safety profile of the PIKA Rabies Vaccine is favorable, indicating high tolerability.

Chief Medical Officer Dr. Zenaida Mojares underscored the significance of these interim results, pointing out the vaccine's robust immune response and safety. She emphasized that the shorter treatment duration could enhance patient compliance and improve overall outcomes. Dr. David Shao, Director, President, and CEO of YS Biopharma, expressed gratitude to the trial participants and highlighted the company's commitment to collaborating with regulatory bodies in various countries to facilitate the vaccine's approval and availability.

YS Biopharma is a global entity operating in multiple regions, including China, the United States, Singapore, and the Philippines. It focuses on innovative vaccine technologies and therapeutic biologics aimed at combating infectious diseases and cancer. The company is guided by a team with extensive local and international expertise in the biopharmaceutical industry.