AstraZeneca’s global biologics research and development arm, MedImmune, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen that 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 represents 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 prevent serious bacterial infections, such as nosocomial pneumonia, rather than solely relying on antibiotics to treat them,” said Steve Projan, Ph.D., 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. This will hopefully result in us getting 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 and expensive-to-treat staph infections in hospitalised patients.
A drug that receives Fast Track designation is eligible for some or all of the following – Accelerated Approval and Priority Review, if relevant criteria are met; Rolling Review of its Biological License Application (BLA); and more frequent meetings and written correspondence from FDA about the drug’s development and clinical trials.
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.
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.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation 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. For more information please visit: www.astrazeneca.com.
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|Tracy Rossin||+ 1 301 398-1468||(MedImmune)|
|Susannah Budington||+1 301 398 6717||(MedImmune)|