LakeShore Biopharma has commenced the submission of 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).
The application is supported by data from the global Phase III trial that met primary endpoints.
The comparator-controlled, randomised, multicentre and double-blind study enrolled 4,500 participants from the Philippines and Pakistan.
In the trial, the vaccine was shown to offer accelerated protection and met the World Health Organization's objective to shorten rabies vaccine regimens from three or four weeks to just one week.
The geometric mean titers of rabies virus-neutralising antibodies and the seroconversion rate at Day 14 among the first 900 subjects were the trial’s primary immunogenicity endpoints.
Results showed an accelerated and higher seroconversion rate without compromising safety, as the PIKA Rabies Vaccine maintained a highly tolerable safety profile.
The PIKA Rabies Vaccine leverages LakeShore's PIKA adjuvant technology targeting the immunological pathway of toll-like receptor 3, to potentially elicit a stronger and faster immune response than the other vaccines.
The US Food and Drug Administration previously granted orphan drug designation status to the vaccine for rabies virus infection prevention and PEP.
LakeShore Biopharma CMO Dr Zenaida Mojares said: “Our existing rabies 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.
“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.”
