WESTON, Fla.--(BUSINESS WIRE)--ILiAD Biotechnologies announces enrollment of the first participants in the SUPER Trial (Standing Up to PERtussis) – the first study in school-age children of BPZE1, a live attenuated intranasal pertussis vaccine. The SUPER Trial is a multicenter, randomized, placebo-controlled, and observer-blinded Phase 2b study in healthy school age children across 12 to 16 sites in the United Kingdom and Australia to assess the immunological response and safety profile of a single dose of BPZE1 with and without co-administration of BOOSTRIX®. Approximately 600 participants 6 to 16 years old will be randomly assigned to one of three study groups.
Previously in September 2020, ILiAD reported 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.
The primary immunogenicity outcome for the SUPER trial is mucosal S-IgA in nasal secretions and induction of serum IgG in blood samples on Day 29. The primary safety outcomes are solicited adverse events (AE’s) for 7 days post each vaccination and safety laboratory results. A sub-study will be conducted with a primary endpoint of colonization after attenuated B. pertussis challenge. An important secondary measure in the sub-study is the proportion of participants that induce 50% killing titers of serum bactericidal activity.
Neal Halsey, MD, former Chair of the Committee on Infectious Diseases of the American Academy of Pediatrics and current ILiAD Scientific Advisory Board member stated that, “While current acellular vaccines (aPV) were introduced in the U.S. in the 1990’s and have proven safer than older whole cell vaccines (wPV), they have not met expectations for reducing the burden of pertussis. Individuals younger than 25 years of age and born in the U.S. have only been vaccinated in infancy with aPV (i.e. “primed” with aPV), which may affect the immunological protection when boosted with a pertussis vaccine during adolescence and adulthood. Previous adult studies of BPZE1 included participants that were predominantly “primed” with wPV during childhood. The SUPER Trial will allow evaluation of BPZE1 in a cohort of participants that were primed with aPV during childhood.”
“Studying BPZE1 in a school age population will provide important information about boosting immunological protection of children and adolescents who have high rates of B. pertussis colonizing infections and serve as a major reservoir for transmission to vulnerable infants,” said Dr. Keith Rubin, Chief Executive Officer of ILiAD. Dr. Rubin added, “The need for a safe and more effective pertussis vaccine is well recognized, and BPZE1’s ability to induce robust mucosal and systemic immunity continues to be supported by ongoing clinical and laboratory evidence, giving us further confidence that BPZE1 holds the potential to ultimately eradicate disease due to B. pertussis.”
BPZE1 is the most advanced next generation pertussis vaccine in the world. Developed in the lab 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 designed to overcome deficiencies of current vaccines, including poor durability 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. In addition to the 300-participant Phase 2b study, a Phase 2a BPZE1 study was conducted at the Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU), sponsored by the National Institute of Allergy and Infectious Disease (NIAID) at the National Institute of Health (NIH).
About Pertussis
Pertussis (whooping cough) is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis. According to U.S. Centers for Disease Control and Prevention, each year pertussis affects approximately 16 million people globally, accounting for nearly 200,000 deaths. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics. In addition, current vaccines do not fully protect infants under age 6 months, since immunization requires multiple injections, usually at 2, 4 and 6 months.
About BPZE1
BPZE1 is a next-generation live-attenuated pertussis vaccine designed to induce comprehensive and durable protection against B. pertussis infection (colonization) and disease (whooping cough). BPZE1 is being developed to block B. pertussis from colonizing adult and adolescent nasal passages, to protect adults and adolescents from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and adolescents and to indirectly protect vulnerable infants, future development aims to immunize neonates directly.
About ILiAD Biotechnologies, LLC
ILiAD Biotechnologies (http://www.iliadbio.com) is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials.
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In addition to historical facts or statements of current, this press release may contain forward-looking statements. Forward-looking statements provide ILiAD’s current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products, interpretation of clinical results, prospects for regulatory approval, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, rapid technological change, risks associated with acquisitions and investments, risks associated directly with BPZE technologies including but not limited to uncertainties of product development, and uncertainties of clinical development, dependence on third parties, competition, protection of patents and proprietary technology, potential for infringement and other statements regarding matters that are not historical fact. Some of these forward looking statements may be identified by use of words in the statements such as “estimate,” “intend,” or other words and terms of similar meaning. Statements in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore actual outcomes and results may differ materially from what is expressed in such forward-looking statements. ILiAD cautions investors not to place reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this release and ILiAD undertakes no obligations to update or review these statements, except as may be required by law.
