FDA Grants ILiAD Biotechnologies Fast Track Designation for Next Generation Pertussis Vaccine BPZE1
ILiAD Biotechnologies, a late stage biotech development company focused on global eradication of disease due to Bordetella pertussis, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BPZE1, a next generation vaccine for active booster immunization against pertussis.
BPZE1 is the most advanced next generation pertussis vaccine currently in clinical development. Developed in the laboratory of Camille Locht, PhD, at the Institut Pasteur de Lille (IPL) and French National Institute of Health and Medical research (https://www.inserm.fr/en), BPZE1 is a live-attenuated intranasal vaccine designed to overcome deficiencies of current pertussis vaccines, including poor durability of protection and failure to prevent nasopharyngeal Bordetella pertussis infections that lead to escape mutants and transmission to vulnerable infants. Four clinical trials studying BPZE1 in healthy adults have been completed to date, including positive topline results from a 300-participant adult Phase 2b trial demonstrating that BPZE1 induced durable mucosal immunity and reduced nasal colonization — two key factors necessary for the prevention of transmission and reduction of epidemic pertussis cycles. Earlier this month, the Company also announced initiation and enrollment of the first participants in the BPZE1 SUPER Trial (Standing Up to PERtussis) – the fifth clinical BPZE1 study and the first study in school-age children.
Section 506(b) of the FD&C Act provides for the designation of a drug as a Fast Track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.” Fast Track provides opportunities for frequent Company interactions with the FDA and the potential for accelerated approval and priority review.
“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, Chief Executive Officer of ILiAD. Dr. Rubin added, “We look forward to continuing to work with the FDA and other global Regulatory Agencies to further clinical development of BPZE1 and to safely and efficiently bring BPZE1 to US and global markets.”
January 6, 2022
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