FDA fast track designation for development of MEDI3902 for prevention of nosocomial pneumonia

AstraZeneca has announced that its global biologics research and development arm, MedImmune, has received fast track designation from the US Food and Drug Administration (FDA) for its investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa).


Pseudomonas aeruginosa (P. aeruginosa) causes serious disease in hospitalised patients. The FDA’s Fast Track programme is a process designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.

MEDI3902, currently entering Phase I clinical trials, is a novel mAb engineered to combine three distinct mechanisms of action for disarming and clearing P. aeruginosa. In pre-clinical trials, MEDI3902 was found to produce enhanced effects for both prevention and treatment of the problematic bacterial infection in multiple animal models. Prophylactic use of MEDI3902 will be investigated as a potentially new therapeutic approach for controlling pneumonia in hospitalised patients.

“We are pleased that the FDA has granted Fast Track designation for MEDI3902, recognising 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,” said Steve Projan, PhD, FAAM, Senior Vice President, R&D and Infectious Diseases & Vaccines iMED Head, MedImmune.

“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. 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.”

MedImmune is exploring ways of using biologics to help prevent and treat challenging infectious diseases, including P. aeruginosa. Recent preclinical studies with P. aeruginosa have demonstrated that engineered multi-mechanistic mAbs may not only protect against infection and work synergistically with marginally active antibiotics against drug-resistant strains, they may also have potential to prevent co-infections with multiple bacteria. MedImmune is also studying MEDI4893, a Phase II clinical candidate mAb targeting Staphylococcus aureus alpha toxin, a bacterial pathogen that can lead to serious staph infections in hospitalised patients.

About MEDI3902
MEDI3902 is an investigational novel bispecific monoclonal antibody engineered to combine three distinct mechanisms of action. This novel antibody design was found to produce enhanced effects for both prevention and treatment of P. aeruginosa infection in multiple animal models.

About P. aeruginosa
P. aeruginosa is a highly drug-resistant bacterial pathogen that causes serious infections in hospitalized patients and/or with people with weakened immune systems. It is the most common pathogen isolated from patients who have been hospitalized longer than one week, and it is a frequent cause of nosocomial infections. An estimated 51,000 healthcare-associated P. aeruginosa infections occur in the United States each year. Pseudomonal infections are complicated and can be life-threatening. P. aeruginosa has been identified as the causative organism in up to 24% of pneumonias in mechanically-ventilated patients, with fatality rates as high as 43% observed in drug-resistant strains.

About MedImmune
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.

For more information, please visit www.medimmune.com


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