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Emergent BioSolutions Initiates Phase 2 Study

For their anti-influenza immune globulin

By: Betsy Louda

, Contract Pharma

 


Emergent BioSolutions Inc. has announced the initiation of a Phase 2 dose ranging study to evaluate the safety, pharmacokinetics, and clinical benefit of FLU-IGIV, the company’s anti-influenza immune globulin being developed as an intravenous treatment for serious illness caused by influenza A infection in hospitalized patients.

 

“Seasonal influenza remains a significant disease burden worldwide that can result in severe disease, hospitalization, and even mortality in vulnerable populations such as the elderly. In our quest towards our mission – to protect and enhance life – Emergent has an opportunity to progress a novel therapeutic that could potentially address this unmet need,” said Dr. Laura Saward, senior vice president and antibody therapeutics business unit head at Emergent. “The use of immune globulins with high neutralizing titers against the influenza virus is being considered as a complementary strategy to treat influenza virus infection and improve outcomes in the hospitalized patient population. FLU-IGIV is being developed by Emergent as a polyclonal antibody therapeutic on our established hyperimmune manufacturing platform.”

 

This Phase 2 clinical study will enroll approximately 75 adult patients hospitalized with serious illness caused by influenza A infection in up to 50 sites within the U.S. The study will evaluate FLU-IGIV in conjunction with standard of care, including a minimum five-day course of an anti-viral drug.

 

FLU-IGIV is a purified immunoglobulin containing a standardized amount of antibody to influenza A virus. It is developed on the company’s hyperimmune platform, on which several marketed antibody therapeutics have been licensed, including Emergent’s Anthrasil [Anthrax Immune Globulin Intravenous (Human)] and VIG [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV). 

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