LakeShore begins BLA submission to DRAP for rabies vaccine

LakeShore Biopharma has initiated the submission process for its biologics license application to the Drug Regulatory Authority of Pakistan (DRAP), seeking conditional approval for its PIKA Rabies Vaccine designed for post-exposure prophylaxis (PEP). This application is backed by data obtained from a global Phase III clinical trial which successfully met its primary endpoints.

The Phase III trial, which was comparator-controlled, randomized, multicenter, and double-blind, included 4,500 participants from the Philippines and Pakistan. The results of the trial demonstrated that the vaccine offered accelerated protection and achieved the World Health Organization’s goal of reducing rabies vaccine regimens from the traditional three or four weeks to just one week.

The primary immunogenicity endpoints of the trial were the geometric mean titers of rabies virus-neutralizing antibodies and the seroconversion rate at Day 14 among the first 900 subjects. These endpoints were successfully met, with the vaccine showing an accelerated and higher seroconversion rate while maintaining a highly tolerable safety profile.

The PIKA Rabies Vaccine utilizes LakeShore’s PIKA adjuvant technology, which targets the immunological pathway of toll-like receptor 3. This technology is designed to elicit a stronger and faster immune response compared to other vaccines. The US Food and Drug Administration has previously granted orphan drug designation to this vaccine for the prevention of rabies virus infection and for post-exposure prophylaxis.

LakeShore Biopharma’s Chief Medical Officer, Dr. Zenaida Mojares, expressed confidence in the vaccine, stating, “Our existing rabies vaccine, YSJA, has already protected tens of millions of patients in China from this fatal disease. We are dedicated to advancing next-generation rabies vaccines with PIKA adjuvant technology to enhance patient protection. The positive outcome of our pivotal trial underscores the potential of PIKA technology to generate a more robust and quicker immune response. We are focused on collaborating closely with drug regulatory agencies across various countries concerning the registration and marketing of this product. We look forward to the early approval of this innovative therapy for the benefit of patients around the world.”