GAITHERSBURG, Md.—MedImmune, the global biologics research and development arm of AstraZeneca, announced today that it has received fast track designation from the U.S. Food and Drug Administration (FDA) for the development of MEDI8897. This high-potency, extended half-life monoclonal antibody (mAb) is being investigated for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children. The FDA’s fast track program is designed to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.
MedImmune previously discovered, developed and currently markets a monoclonal antibody for severe RSV disease. The company aims to increase the number of infants who are protected from LRTI caused by RSV through its development of MEDI8897 for the passive immunization of all infants, term and preterm.
MEDI8897 is an investigational recombinant human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody with an extended half-life that neutralizes RSV by binding the prefusion conformation of the RSV fusion (F) protein expressed on virions and infected cells. MedImmune is pursuing development of MEDI8897 for the passive immunization of all infants entering their first RSV season and children with chronic lung disease or congenital heart disease entering their first and second RSV season for the prevention of lower respiratory tract illness caused by RSV.
“While the burden and seriousness of RSV disease has kept it a global priority for vaccine development for more than 50 years, it is well recognized that a significant unmet medical need continues to exist for the prevention of RSV in all infants worldwide,” said Steve Projan, Ph.D., FAAM, senior vice president, R&D and Infectious Diseases & Vaccines Innovative Medicines Unit head, MedImmune. “We are working with a sense of urgency to develop a next-generation RSV mAb that we believe has the potential to benefit hundreds of thousands more infants, both in the U.S. and around the world. If successful, the fast track designation will enable us to more quickly deliver a preventative solution.”
RSV is the most prevalent cause of lower respiratory tract infections among infants and young children, resulting in annual epidemics worldwide. In children younger than one year of age, RSV is the most common cause of bronchiolitis, an inflammation of the small airways in the lung, and pneumonia. Severe RSV disease causes approximately 125,000 hospitalizations and up to 400 infant deaths each year in the United States alone. There is currently no treatment for RSV once it’s contracted, nor is there an approved preventative therapy for healthy populations.
As part of its development program, MedImmune is applying its proprietary technology to increase the half-life of MEDI8897, so that only one dose will be needed for the entire RSV season. In preclinical in-vivo and in-vitro studies, MEDI8897 exhibited potent antiviral activity against a diverse panel of RSV A and B clinical isolates, demonstrating broad-spectrum antiviral activity against RSV. MEDI8897 is currently being investigated in a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of the antibody in healthy adults. Based upon analysis of interim data from this study, a separate Phase 1b/2a study has been initiated to examine MEDI8897 in healthy preterm infants.
This is the third fast track designation MedImmune has received for its investigational molecules in its infectious disease therapeutic area. In September 2014, the FDA granted fast track status to MEDI3902 to study it for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa, a highly drug-resistant bacterial pathogen that causes serious disease in hospitalized patients. Fast track designation was also granted to MEDI4893 in late 2014 to study it for the prevention of nosocomial pneumonia caused by the bacterium Staphylococcus aureus, which is often multidrug resistant.
RSV is a common, seasonal virus contracted by nearly 100 percent of infants by the age of two. RSV occurs in epidemics, varying by geography and timing from year to year. The virus leads to a mild respiratory infection with symptoms similar to the common cold or flu, but can develop into a much more serious infection. Severe RSV disease is the leading cause of hospitalization for babies during their first year of life. It results in up to 10 times as many infant deaths each year as the flu, and is responsible for one of every 13 pediatrician visits and one of every 38 trips to the ER in children under the age of five.
MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
