6 July 2020
Global biotherapeutics leader CSL Behring today announced that the first patient has been enrolled in its Phase 2 study to assess the safety and efficacy of CSL312 (garadacimab, Factor XIIa antagonist monoclonal antibody) to treat patients suffering from severe respiratory distress, a leading cause of death in patients with COVID-19 related pneumonia.
In this multicenter, double-blind, placebo-controlled study, approximately 124 adult patients testing positive for the SARS CoV-2 infection will be randomized to receive either CSL312 or placebo, in addition to standard of care (SOC) treatment. The primary endpoint being the incidence of tracheal intubation or death.
“The greatest clinical challenge in treating patients with severe COVID-19 and improving outcomes has been our ability to manage the serious respiratory complications associated with the disease,” said Lars Groenke, R&D Lead, Respiratory Therapeutic Area, CSL Behring. “Our hope with CSL312 is to be able to prevent the progression of COVID-19, improve patient outcomes, and provide physicians with an effective tool in the fight against this deadly virus.”
Currently, CSL Behring is evaluating five approaches across its plasma fractionation and recombinant and antibody strategic scientific platforms to preventing and treating COVID-19.
In addition to the study of CSL312, CSL Behring:
“When it comes to COVID-19, we have gone all in on the battle and are in the fight together with many external partners,” said Bill Mezzanotte, MD, MPH, Executive Vice President, Head of Research and Development, and Chief Medical Officer for CSL Behring. “Whether it is preventative with vaccines, or preventing progression with a hyperimmune, or using our monoclonal antibodies, like CSL312, to help people who are experiencing severe respiratory complications, CSL has taken on projects we think make sense both scientifically and that fit our capabilities. In this way we are most likely to deliver on our promise to patients by helping find solutions to stop this virus and to treat the damage it inflicts on people.”
Read the full media release here.