Under the trial, which is being undertaken in Stockholm, Sweden, two higher doses and volumes of BPZE1, 108 CFU and 109 CFU, will be studied as a follow-up to a prior phase 1 trial.
The original trial suggested that BPZE1 is safe in healthy adults at doses up to 107 CFU and can induce immune responses targeting Bordetella pertussis (B. pertussis) bacteria, ILiAD said.
The phase 1b trial intends to demonstrate safety at higher doses and investigate if a greater proportion of subjects attain BPZE1-induced immune responses with the increase of dose values.
BPZE1 is designed to induce immunity and offer durable protection against whooping cough. It blocks B. pertussis from colonizing the adult nasal passage, potentially avoiding transmission to infants.
ILiAD Biotechnologies CEO Keith Rubin said: "In light of increasing evidence that nasopharyngeal B. pertussis colonization is a critical factor in the rise of pertussis disease, and given the promise of BPZE1 to induce potent mucosal immunity, our latest clinical milestone is another example of ILiAD’s commitment to commercialize BPZE1 and solve the global problem of pertussis once and for all."
The company has so far raised more than $5m and, apart from phase 1b enrollment, several important milestones were achieved.
BPZE1 technology is covered by 14 issued patents, with a further 30 patents pending across the world.
In a non-human primate model, ILiAD demonstrated that BPZE1 effectively protects against both whooping cough and B. pertussis nasopharyngeal colonization.
Image: BPZE1 is designed to induce immunity and offer durable protection against whooping cough. Photo: courtesy of Serge Bertasius Photography/FreeDigitalPhotos.net.