CSL Behring has started enrolment in a Phase II clinical trial of CSL312 for the treatment of patients with severe respiratory distress caused by Covid-19-related pneumonia.
CSL312 (garadacimab) is a Factor XIIa antagonist monoclonal antibody that is being assessed as a potential treatment for conditions where FXIIa inhibition may improve clinical outcomes.
The multi-centre, double-blind, placebo-controlled Phase II trial will investigate the safety and efficacy of the drug candidate in about 124 adults with Covid-19.
Participants will be administered with CSL312 or placebo, along with standard of care. The primary endpoint of the study is the incidence of tracheal intubation or death.
CSL Behring respiratory therapeutic area R&D Lead Lars Groenke said: “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.
“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.”
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Previously, the company collaborated with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Queensland (UQ) to develop, manufacture, and distribute a Covid-19 vaccine candidate.
CSL Behring is also part of the CoVIg-19 Plasma Alliance focused on developing unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine for individuals with serious Covid-19 complications.
In addition, the company is working on a plasma product against Covid-19 for the Australian market to potentially treat patients with serious Covid-19 complications, primarily those progressing towards ventilation.
It also formed an alliance with SAB Biotherapeutics to advance and deliver a new immunotherapy targeting Covid-19. Clinical trials of the medicine are set to launch in North America in the coming months.