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Monoclonal antibody granted fast track designation for prevention of nosocomial pneumonia

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The FDA today gave fast track designation to AstraZeneca’s investigational monoclonal antibody for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa, according to a news release from the drugmaker.

The monoclonal antibody, MEDI3902, is now entering phase 1 clinical trials. According to MedImmune, the global biologics research and development arm of AstraZeneca, the treatment is designed to combine three distinct mechanisms of action for treating P. aeruginosa. Researchers are now investigating the prophylactic use of MEDI3902 as a way of controlling pneumonia in hospitalized patients.

“We are pleased that the FDA has granted fast track designation for MEDI3902, recognizing the unique science behind this investigational monoclonal antibody and the importance of accelerating development of new medicines that may help prevent serious bacterial infections, such as nosocomial pneumonia, rather than solely relying on antibiotics to treat them,” Steve Projan, PhD, senior vice president of research and development and head of infectious diseases and vaccines at MedImmune’s innovative medicines unit, said in the release.

Preclinical studies indicate that engineered multi-mechanistic monoclonal antibodies may not only protect patients against P. aeruginosa infection and augment conventional antibiotics in the treatment of drug-resistant infections, but they may also protect against coinfections from multiple bacteria, according to the company.

Meanwhile, MedImmune is conducting phase 2 clinical studies of another monoclonal antibody, MEDI4893, which targets Staphylococcus aureus alpha toxin.

“At a time when antimicrobial resistance poses an imminent and urgent global public health threat, it’s more important than ever to develop new therapies that both prevent and treat hospital-acquired infections,” Projan said. “The fast track designation will streamline communications with the FDA throughout the development process on what is a very different approach to the bacterial resistance problem. If successful, we hope to bring this important new medicine to patients as quickly as possible.”