Global biotherapeutics leader 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.    

"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:

Has entered into a partnering agreement with the Coalition for Epidemic Preparedness Innovations (CEPI), 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.

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. The collaboration will leverage leading-edge expertise and work that the companies already have underway.

Is developing an anti-SARS-CoV-2 plasma product for the Australian market with the potential to treat people with serious complications of COVID-19, particularly those whose illness is progressing towards the need for ventilation. The investigational product, to be known as COVID-19 Immunoglobulin, is under development at the company's advanced manufacturing facility located in Broadmeadows, Victoria.

Has also formed a partnership with SAB Biotherapeutics, a clinical-stage biopharmaceutical company, to advance and deliver a novel immunotherapy targeting COVID-19. The potential therapy would be produced without the need for blood plasma donations from recovered COVID-19 patients. Clinical trials could begin this summer in North America. 

"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."

About CSL312 (Garadacimab)
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 (HAE), 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 U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to garadacimab as an investigational therapy for the prevention of bradykinin-mediated angioedema.

About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

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