LakeShore Biopharma Co., Ltd (Nasdaq: LSB) has announced the approval of a Phase III clinical trial by China's National Medical Products Administration (NMPA) to evaluate simplified four-dose regimens of its YSJA rabies vaccine. The trial, expected to commence in December 2024, will assess the immunogenicity and safety of these regimens compared to the existing five-dose Essen regimen. This development aims to provide more flexible immunization options, reduce the burden on healthcare systems, and improve patient compliance.
The Phase III trial is designed as a single-center, randomized, double-blind, controlled study. It will compare two distinct four-dose immunization schedules: the Zagreb regimen (2-1-1), involving two shots in the first session followed by one shot in each of the subsequent two sessions, and the Modified Essen regimen (1-1-1-1), consisting of a single shot across four sessions. The primary endpoints will focus on evaluating the immunogenicity and safety profiles of these simplified regimens relative to the conventional Essen regimen (1-1-1-1-1).
Rationale for Simplified Regimens
The conventional five-dose Essen regimen, while effective, can be challenging for patients to complete due to the multiple required visits. Simplified regimens offer the potential to enhance patient adherence, reduce physician workload, and minimize hospital visits, ultimately decreasing the financial burden on patients. According to LakeShore Biopharma, these advantages could significantly improve the vaccine's utility and contribute to the prevention of rabies deaths.
Executive Commentary
"The approval of this Phase III clinical trial for our YSJA rabies vaccine marks a significant milestone in our efforts to expand the regimen profile of our product," said Mr. Xu Wang, Chief Executive Officer of LakeShore Biopharma. "By evaluating simplified immunization schedules, we aim to make our vaccine more competitive in the rapidly expanding rabies vaccine market. We believe that this trial will validate the clinical superiority of the YSJA rabies vaccine and will help attract increased recognition and support from researchers, academics, and industry players around the world."
Rabies: A Global Health Threat
Rabies remains a significant global health concern, with an almost 100% fatality rate upon the emergence of clinical symptoms. The disease claims approximately 59,000 lives annually across more than 150 countries. Transmission primarily occurs through bites from infected dogs, accounting for over 95% of rabies-related fatalities. Notably, 40% of these deaths occur in children under the age of 15. While rabies is typically lethal without treatment, post-exposure prophylaxis (PEP) can effectively prevent fatalities if administered promptly following potential exposure.
About YSJA Rabies Vaccine
The YSJA rabies vaccine is LakeShore Biopharma's flagship product, with over 100 million doses sold since its market approval. The company aims to solidify its position as a leading rabies vaccine supplier through this clinical trial and other ongoing efforts. LakeShore Biopharma is dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer.
