GAITHERSBURG, Md., April 15 /PRNewswire/ -- MedImmune today announced that it has advanced its efforts to develop CAT-354, a potential treatment for patients with asthma, with the start of two new trials with a monoclonal antibody (MAb) targeting interleukin-13 (IL-13). One of the studies is a Phase 2 clinical trial in Europe and Australia designed to assess the potential of the anti-IL-13 MAb in patients with uncontrolled asthma despite optimal treatment. The company has also begun dosing patients in the first U.S.-based clinical trial of the antibody, a Phase 1 study to assess pharmacokinetics in healthy adult patients.
"We are pleased to advance CAT-354 into its first Phase 2 clinical trial to assess the antibody's potential to help patients with asthma gain control of their often debilitating symptoms," said Barbara White, M.D., vice president, clinical development, inflammatory disease. "Initiating our clinical work in the U.S. is also an important step in bolstering the depth of data we are gathering for this potential asthma treatment."
The Phase 2 clinical trial is designed to assess the effects of CAT-354 on airway hyperresponsiveness in patients with uncontrolled asthma. This randomized, double-blind, placebo-controlled study has started in Europe and Australia.
The first Phase 1 clinical trial of CAT-354 in the U.S. is designed to compare the pharmacokinetics of the antibody when administered via subcutaneous injection versus intravenous infusion in healthy patients. This randomized, open-label, study in healthy male patients marks the first clinical trial to assess the subcutaneous administration of CAT-354, as previous studies have used intravenous infusion administration.
CAT-354, a recombinant human monoclonal antibody of the G4 subclass, targets IL-13. Early pre-clinical data have shown the potential of the antibody to treat varying degrees of asthma. The effects of CAT-354 have been investigated in in vitro and in vivo systems and Phase 1 data in mild to moderate asthmatic volunteers demonstrated the safety and tolerability of the monoclonal antibody, thus supporting its continued development.
About Interleukin-13 (IL-13)
Preclinical data has demonstrated that IL-13 plays an important role in asthma. It is one of at least 29 naturally occurring interleukins in the human body. Overexpression of IL-13 in animal models has been shown to result in many of the features associated with human asthma. IL-13 is believed to be a relevant target for treating asthma, considering its potential role in airway obstruction and in chronic airways remodeling, as seen in animal models.
Clinical Development in Asthma
MedImmune has multiple approaches in development targeting asthma. Currently, in human testing the company has antibodies targeting IL-9 (MEDI 528) and IL-13 (CAT-354), each in Phase 2 development, and an anti-IL-5 receptor (MEDI 563), which is in Phase 1 development. In addition, the company has a number of antibodies that are anticipated to be designated as drug candidates.
Asthma is a chronic disease of the airways that may cause wheezing, breathlessness, chest tightness and coughing. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 30 million Americans reported having a history of asthma in 2003, including nine million children. About 20 million said they currently had asthma. In 2000, the CDC reported that there were more than 10 million asthma-related outpatient visits to private physician offices and hospital clinics. The National Institutes of Health (NIH) have estimated asthma-related healthcare costs in the U.S. at $14 billion annually.
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on cardiovascular/gastrointestinal disease, neuroscience, oncology, infection, respiratory disease and inflammation. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.