Phase 3 Data Regarding Anti-RSV Antibody To Be Presented at Pediatric Academic Societies (PAS) Annu...( - In Clinical Trial Motavizumab...),Health

- In Clinical Trial, Motavizumab Reduced Hospitalizations Due to

Respiratory Syncytial Virus by 83 Percent Compared to Placebo -

HONOLULU, May 4 /PRNewswire/ -- MedImmune today announced that researchers are currently presenting results from a MedImmune-sponsored Phase 3 study involving motavizumab, an investigational monoclonal antibody (MAb) that is being evaluated for its potential to prevent serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients. Kate O'Brien, M.D., M.P.H., associate professor at the Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, is the study's principal investigator. Aruna Chandran, M.D., M.P.H., a trial co-investigator, presents the data today at the Pediatric Academic Societies (PAS) Annual Meeting in Honolulu, HI.

This randomized Phase 3 study demonstrated that motavizumab reduced hospitalizations due to RSV by 83 percent as compared to placebo (8.3 percent in placebo arm versus 1.4 percent in motavizumab; p<0.001), as the trial's primary endpoint. In addition, the trial showed a 71-percent reduction in the incidence of RSV-specific lower respiratory infections (LRIs) requiring outpatient management (9.5 percent in placebo group and 2.8 percent in the motavizumab group; p<0.001), which was a secondary endpoint.

The randomized, double-blind Phase 3 study involving 1,410 full-term healthy infants less than six months of age in some Southwest Native American populations was designed to compare monthly intramuscular injections of motavizumab against placebo. In previous epidemiologic studies these populations were shown to have high rates of hospitalization due to RSV. This study confirmed the high rates of serious RSV disease in this population. An interim analysis, reviewed by an independent data safety monitoring committee, concluded there was statistical evidence demonstrating that motavizumab reduced RSV hospitalizations and LRIs
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