AstraZeneca’s global biologics R&D arm MedImmune has picked up a fast track designation in the US for its investigational treatment for patients hospitalised with Type A strain influenza, which could help accelerate its development pathway.
MEDI8852 is currently in a Phase Ib/IIa clinical trial assessing the safety and efficacy of a single intravenous dose in combination with the anti-viral Tamiflu (oseltamivir), and as a monotherapy in adult patients with confirmed acute, uncomplicated influenza caused by Type A strains.
A recently completed Phase I study in healthy adult subjects showed that the monoclonal antibody had an acceptable safety and pharmacokinetics profile supporting its continued development in patients, AZ noted.
Steve Projan, R&D and Infectious Diseases & Vaccines iMED head at MedImmune, has applauded the FDA’s decision to grant fast-track status as it “recognises the importance of accelerating the development of new medicines for the prevention and treatment of challenging infectious diseases”.
Worldwide annual epidemics of flu are estimated to result in about 3 to 5 million cases of severe illness, and about 250,000 to 500,000 deaths, highlighting the urgent need for new therapeutic agents.
MEDI8852 is being developed as a treatment for seasonal influenza disease, but it is anticipated that it could also be used in the pandemic setting, according to the firm.