According to Iliad Biotechnologies, the FDA has granted Fast Track designation to Iliad’s BPZE1 live attenuated intranasal vaccine against pertussis (whooping cough), which is in Phase 2 development as a booster vaccine to prevent both colonization by B. pertussis and disease caused by the bacterium.
Iliad licensed the intranasal pertussis vaccine, which was developed at the Institut Pasteur de Lille (IPL) and the French National Institute of Health and Medical Research (Inserm), in 2014. The company recently initiated a Phase 2b trial of BPZE1 in children aged 6 to 16 and has previously completed 4 trials in healthy adults.
Iliad CEO Keith Rubin said, “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. 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.”
Read the Iliad Biotechnologies press release.
