The Food and Drug Administration (FDA) has granted Fast Track designation to BPZE1 for active booster immunization against pertussis.
BPZE1 is an investigational live-attenuated intranasal vaccine designed to induce comprehensive and durable protection against Bordetella pertussis (B. pertussis) infection and disease. By blocking B. pertussis colonization in nasal passages, the vaccine may also prevent transmission, thereby reducing the incidence of pertussis disease. The designation is supported by data from 4 clinical trials evaluating BPZE1 in healthy adults.
Topline results from a phase 2b trial (ClinicalTrials.gov Identifier: NCT03942406) showed that BPZE1 induced durable mucosal immunity and reduced nasal colonization in adults following intranasal administration. BPZE1 is also being evaluated in the randomized, placebo-controlled, observer-blinded phase 2b SUPER trial (ClinicalTrials.gov Identifier: NCT05116241), which will enroll approximately 600 healthy participants 6 to 16 years of age.
“We are pleased that the FDA is aligned with ILiAD’s position that there is an unmet clinical need for a more effective pertussis vaccine and that the evidence to date supports the potential for BPZE1 to address the major gaps in protection against pertussis,” said Dr Keith Rubin, CEO of ILiAD.
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need such as providing a therapy that may be better than currently available treatments.
FDA grants ILiAD Biotechnologies Fast Track designation for next generation pertussis vaccine BPZE1. News release. ILiAD Biotechnologies. January 3, 2022. Accessed January 4, 2022. https://www.businesswire.com/news/home/20211231005068/en/FDA-Grants-ILiAD-Biotechnologies-Fast-Track-Designation-for-Next-Generation-Pertussis-Vaccine-BPZE1.