Emergent BioSolutions announces topline data from NIAID Phase III ITAC trial (INSIGHT-013) of immunoglobulins as a treatment for hospitalized patients with COVID-19.

Emergent BioSolutions Inc. provided an update on the evaluation of its investigational SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) for the treatment of hospitalized patients with COVID-19 . The Phase III Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) trial, also known as INSIGHT-013, sponsored and supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), assessed the safety and efficacy of four immunoglobulin candidates plus standard of care versus placebo plus standard of care in hospitalized patients with COVID-19. Topline data from the ITAC trial demonstrated that the addition of anti-SARS-CoV-2 hyperimmunoglobulin to standard of care, inclusive of remdesivir, for hospitalized adult COVID-19 patients with symptoms for less than 12 days did not provide clinical benefit when compared to standard of care plus placebo. There were no serious safety concerns identified. "While we are disappointed by these data in hospitalized patients where there remains a high unmet need, we recognize that, similar to other antibody-based therapies, intervention with COVID-HIG earlier in the disease course may be necessary to impact COVID-19 in patients,” said Dr. Laura Saward, SVP and therapeutics business unit head at Emergent BioSolutions. “Emergent will continue to explore COVID-HIG as a treatment in ongoing clinical trials. The public-private partnership with NIAID and the Biomedical Advanced Research and Development Authority (BARDA) has been important to generate data on the COVID-HIG investigational product. We also would like to thank all study participants, sites, and investigators across the globe who contributed to this effort.” COVID-HIG is also being developed as a potential treatment for outpatients at high risk of progression to severe disease with funding from BARDA. It is also being supported with funding from the U.S. Department of Defense.