FDA Grants ILiAD Biotechnologies Fast Track Designation for Next Generation Pertussis Vaccine BPZE1
WESTON, Fla.--(BUSINESS WIRE)--ILiAD Biotechnologies, a late stage biotech development company focused on global eradication of disease due to Bordetella pertussis, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BPZE1, a next generation vaccine for active booster immunization against pertussis.
BPZE1 is the most advanced next generation pertussis vaccine currently in clinical development. Developed in the laboratory 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 a live-attenuated intranasal vaccine designed to overcome deficiencies of current pertussis vaccines, including poor durability of protection 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, including 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. Earlier this month, the Company also announced initiation and enrollment of the first participants in the BPZE1 SUPER Trial (Standing Up to PERtussis) – the fifth clinical BPZE1 study and the first study in school-age children.
Section 506(b) of the FD&C Act provides for the designation of a drug as a Fast Track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.” Fast Track provides opportunities for frequent Company interactions with the FDA and the potential for accelerated approval and priority review.
“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,” said Dr. Keith Rubin, Chief Executive Officer of ILiAD. Dr. Rubin added, “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.”
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.
About Fast Track Designation
Fast Track Designation by the U.S. FDA is a process designed to facilitate the development and expedite the review of investigational products to treat serious conditions and fill an unmet medical need, with the intent of getting important new products to the population in an expedited manner. Specifically, Fast Track Designation provides the option of licensure via the accelerated approval pathway, which allows licensure based on surrogate endpoints. Additionally, Fast Track designation facilitates meetings with the FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available. This permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. Priority review (six-month review versus standard 10-month review) is an additional benefit that may potentially be available for BPZE1 as part of the Fast Track designation.
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.