LakeShore Submits BLA to DRAP for PIKA Rabies Vaccine Following Positive Phase III Results
核心洞察
LakeShore Biopharma has initiated the BLA submission to Pakistan's DRAP for its PIKA Rabies Vaccine, targeting post-exposure prophylaxis.
Phase III trial data supports the application, demonstrating the vaccine's ability to accelerate protection against rabies (搜索).
The trial met primary immunogenicity endpoints, showing a rapid seroconversion rate and a tolerable safety profile.
LakeShore Biopharma has begun submitting its biologics license application (BLA) to the Drug Regulatory Authority of Pakistan (DRAP), seeking conditional approval for its PIKA Rabies Vaccine for post-exposure prophylaxis (PEP). This application is supported by data from a global Phase III trial that met its primary endpoints, potentially offering a faster and more effective rabies (搜索) prevention strategy.
The comparator-controlled, randomized, multicenter, and double-blind Phase III study involved 4,500 participants from the Philippines and Pakistan. The trial demonstrated the vaccine's ability to provide accelerated protection, aligning with the World Health Organization's (WHO) objective to reduce rabies (搜索) vaccine regimens from three or four weeks to a single week.
The primary immunogenicity endpoints of the trial focused on the geometric mean titers of rabies virus (搜索)-neutralizing antibodies and the seroconversion rate at Day 14 among the first 900 subjects. Results indicated an accelerated and higher seroconversion rate without compromising safety. The PIKA Rabies Vaccine maintained a highly tolerable safety profile throughout the study.
PIKA Adjuvant Technology
The PIKA Rabies Vaccine incorporates LakeShore’s PIKA adjuvant technology, which targets the toll-like receptor 3 (搜索) immunological pathway. This approach is designed to elicit a stronger and faster immune response compared to traditional vaccines. The US Food and Drug Administration (FDA) previously granted orphan drug designation to the vaccine for rabies virus (搜索) infection prevention and PEP.
Expert Commentary
LakeShore Biopharma CMO Dr. Zenaida Mojares stated, "Our existing rabies (搜索) vaccine, YSJA, has protected tens of millions of patients in China from this deadly disease. We are committed to advancing next-generation PIKA adjuvanted rabies vaccines to enhance patient protection."
Dr. Mojares added, "The promising results from our pivotal trial validate the potential of PIKA technology to generate a stronger and faster immune response. We remain committed to working closely with drug regulatory agencies in various countries regarding the product registration and marketing application. We eagerly anticipate the early approval of this innovative therapy for the benefit of patients worldwide."