WESTON, Fla.--(BUSINESS WIRE)--ILiAD Biotechnologies, LLC (ILiAD), a clinical stage biotech company developing the world’s most advanced next generation pertussis vaccine, today announced full enrollment of its Phase 2b study.
On October 3, 2019, ILiAD Biotechnologies completed subject enrollment in its IB-200P multicenter, randomized, placebo-controlled, and observer-blinded study of BPZE1. BPZE1 is a live attenuated intranasal pertussis vaccine being studied in healthy adults to assess the immunological response and safety profile of single dose and two dose vaccination schedules. The study has now randomly assigned 300 subjects in a 2:1 ratio to a first (primary) vaccination, with 200 subjects assigned to BPZE1 vaccination and 100 subjects to Boostrix™ (currently marketed vaccine). The study design includes a second (boost) vaccination 3 months after subjects receive their primary dose. For the second dose, half the subjects will receive a boost dose of BPZE1 and half will receive an intranasal placebo.
The primary immunogenicity endpoint of the study is the proportion of subjects who achieve mucosal seroconversion against at least 1 pertussis antigen in nasal secretions on Day 29 or 113 (prime or prime + boost). The primary safety endpoints are solicited AE’s for 7 days post each vaccination and safety laboratory results. Important secondary measures are systemic immunogenicity (IgG, IgA, and IgG or IgA) including the proportion of subjects that are seropositive to 2 or more pertussis antigens in serum, mucosal immunity including the proportion of subjects generating a seropositive response to 2 or more pertussis antigens in nasal secretions, and the proportion of subjects with BPZE1 nasopharyngeal colonization after boosting vaccination.
“Completing Phase 2b enrollment is a significant milestone for ILiAD and is expected to result in key study data being available at the end of Q1 2020. The efficient enrollment of study subjects resulted directly from the focused and professional efforts of the study team at our CRO, PPD. We are grateful to PPD and most especially to the study volunteers for their invaluable participation,” said Dr. Keith Rubin, Chief Executive Officer of ILiAD. Dr. Rubin added, “From day 1, ILiAD has been dedicated to eradicating disease due to B. pertussis. By completing Phase 2b enrollment, we are another step closer to confirming whether BPZE1 can provide the robust mucosal and systemic immunity required to more comprehensively protect our global community from the damaging effects of pertussis infections.”
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. In 2018, a Phase 2a BPZE1 study was initiated 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). Prior to the Phase 2a, two Phase 1 studies were completed at the Karolinska University Hospital in Stockholm.
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.
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. BPZE1 is an investigational product. The FDA has not yet established the safety and effectiveness of BPZE1.
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.
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. The company’s clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 22,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit http://www.ppdi.com.
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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.