ILiAD Biotechnologies, a Florida-based biotech company, is celebrating a significant milestone in the development of its whooping cough vaccine. In a phase 2b CHAMPION-1 trial, ILiAD’s nasal vaccine, known as BPZE1, demonstrated promising results by protecting against colonization by the Bordetella pertussis bacterium, which causes whooping cough. This achievement marked a successful outcome for the study’s primary endpoint within the per-protocol population.
Collaborating with universities in the United Kingdom, ILiAD conducted the trial by administering BPZE1 or a placebo to 53 healthy adults. Subsequently, 46 of the participants were exposed to B. pertussis two to four months later. The analysis, focused on the per-protocol group, rather than the broader intention-to-treat analysis, was chosen due to specific challenges in the inoculation process that impacted some individuals.
“The dramatic reduction in quantitative CFU counts in BPZE1 vaccinated participants compared to placebo, over the duration of post-challenge days, reinforces the potential clinical benefit of BPZE1, confirming previously published BPZE1 results in preclinical and attenuated human challenge studies. This study was intended to inform the primary endpoint, study parameters, and sample size to power a successful Phase 3 B. pertussis human challenge study, which we are confident has now been achieved. The primary data from the CHAMPION-1 clinical study will be presented at the World Vaccine Congress on October 19th in Barcelona.”
– Stephanie Noviello, MD, ILiAD Chief Medical Officer
Although ILiAD has not yet released comprehensive data from the trial, apart from a noteworthy 0.03 p-value for the per-protocol analysis, further details are expected to be unveiled at the upcoming World Vaccine Congress next month. The decision to exclude certain patients from the analysis, even though statistically significant results were achieved, raises some questions, but ILiAD is now gearing up for a phase 3 trial.
Currently, children receive vaccinations for whooping cough as part of multi-pathogen shots. However, pertussis still leads to thousands of cases annually. In the United States, there were 18,617 cases reported in 2019, and concerns have arisen regarding waning vaccine immunity. Although breakthrough cases among vaccinated individuals tend to be less severe, ILiAD recognizes the demand for more effective protection against this persistent threat.
“These results represent a major milestone in global public health efforts to control Bordetella pertussis, a pathogen that harms tens of millions of people each year, especially children who account for the great majority of resulting deaths (over 150,000 annually). For more than a decade, ILiAD has been committed to stopping B. pertussis where it lives – the human upper respiratory tract. We’ve always believed that preventing nasopharyngeal colonization will prevent the subsequent disease, transmission and epidemics that have plagued humanity for hundreds of years. We still have a lot of work to do, but this is far and away the best evidence to date that we can fulfill our mission to eradicate all disease due to B. pertussis. My deep appreciation to everyone who contributed to this study, especially the study participants without whom achievement of this important milestone would not be possible.”
– Keith Rubin, M.D., Chief Executive Officer and Founder
ILiAD Biotechnologies’ progress in developing a promising whooping cough vaccine represents a significant step toward addressing this public health concern. As the company advances to the next phase of testing, the potential for enhanced protection against pertussis becomes an even more exciting prospect.