7 July 2020 - - 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, biotherapeutics company CSL Behring said.

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 treatment.

The primary endpoint being the incidence of tracheal intubation or death.

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 has entered into a partnering agreement with the Coalition for Epidemic Preparedness Innovations, and The University of Queensland (UQ) to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate that has been pioneered by researchers at UQ.

CSL Behring is one of the founding members of the CoVIg-19 Plasma Alliance, an unprecedented industry partnership to develop CoVIg-19, a potential plasma-derived therapy for treating COVID-19.

The CoVIg-19 Plasma Alliance will work toward developing the unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19, and to support national governments in their efforts to fight the current pandemic.

Garadacimab is a novel Factor XIIa-inhibitory monoclonal antibody (FXIIa mAb) that CSL Behring is currently investigating for indications where FXIIa inhibition may be a factor in improving clinical outcomes.

These include a recently initiated study to assess garadacimab for prevention of respiratory failure in adult patients with the COVID-19 virus.

Garadacimab is also currently in clinical development as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to hereditary angioedema, a form of bradykinin-mediated angioedema.

Results from this Phase 2 study showed that garadacimab was well tolerated and met the primary endpoint of reduction in attacks in HAE patients.

Garadacimab inhibits the plasma protein, FXIIa. When FXIIa is activated, it initiates the cascade of events leading to edema formation.

By targeting FXIIa, garadacimab can prevent the initiation of this cascade. The US Food and Drug Administration has granted orphan-drug designation to garadacimab as an investigational therapy for the prevention of bradykinin-mediated angioedema.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Ltd. (ASX: CSL) (OTC: CSLLY), headquartered in Melbourne, Australia, employs more than 26,000 people, and delivers its life-saving therapies to people in more than 100 countries.