CSL Behring 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.
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"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.