ILiAD Biotechnologies’ intranasal pertussis vaccine, BPZE1, has received Innovation Passport designation from the UK Medicines & Healthcare Products Regulatory Agency (MHRA). This designation recognizes BPZE1’s potential to address the limitations of existing pertussis vaccines, which do not prevent colonization and transmission, and facilitates expedited development and review in the UK. The designation is for active immunization against both upper respiratory tract •B. pertussis• colonization and symptomatic whooping cough.
This news is significant for both ILiAD and public health. For ILiAD, the designation validates BPZE1’s potential and provides access to enhanced regulatory support, potentially accelerating its path to market. For public health, BPZE1 offers hope for improved pertussis control, particularly given the rising incidence of whooping cough globally and the limitations of current vaccines. The recent outbreaks highlight the urgent need for more effective prevention strategies.
BPZE1 has completed four Phase 2 clinical trials, making it the most advanced pertussis vaccine candidate in development. Developed at the Institut Pasteur de Lille and the French National Institute of Health and Medical Research, BPZE1 is designed to prevent •B. pertussis• colonization, thereby addressing a key shortcoming of current vaccines. Phase 2b trials in adults and children have yielded positive results, with the recent SUPER trial in school-age children demonstrating robust mucosal and systemic antibody responses. Importantly, no interference was observed when BPZE1 was co-administered with the standard Tdap booster. This MHRA designation complements the Fast Track designation previously granted by the US FDA. Both designations offer the potential for accelerated review timelines and rolling reviews, which could expedite BPZE1’s availability in both markets. Pertussis, or whooping cough, remains a global health concern, affecting an estimated 16 million people and causing nearly 200,000 deaths annually, despite a global vaccination coverage of 84%.
The Innovation Passport designation signals a potential paradigm shift in pertussis prevention. If BPZE1 proves successful in Phase 3 trials, it could offer more comprehensive and durable protection against whooping cough, potentially reducing transmission and protecting vulnerable populations, particularly infants. This advancement holds promise for significantly impacting public health by improving disease control and reducing the burden of pertussis worldwide.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
