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CSL has reported positive top-line data from the Phase III VANGUARD clinical trial of garadacimab (CSL312) as a durable preventive therapy for hereditary angioedema (HAE) patients. 

The double-blind, multicentre, randomised, parallel-arm, placebo-controlled trial analysed the safety and efficacy of subcutaneous garadacimab given monthly to prevent HAE attacks versus a placebo for six months. 

According to the findings, the trial met the primary and secondary efficacy objectives.

In the trial, garadacimab was found to have favourable safety and tolerability. 

The company plans to commence the submission of applications seeking full approval to various health agencies globally at the end of this fiscal year.

A new, investigational monoclonal antibody (mAb), garadacimab hinders the plasma protein FXIIa which, on activation, triggers the cascade of events that causes oedema formation. 

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By GlobalData

As against various HAE treatments that act on downstream mediators, the mAb hinders the HAE cascade at its origin by acting on FXIIa.

CSL R&D head, executive vice-president, and chief medical officer Dr Bill Mezzanotte said: “These results underscore our belief that garadacimab has the potential to become a transformative, first-in-class therapy for people living with HAE, a patient group that CSL has been serving for many years. 

“CSL’s promise to patients guides us to meet their unmet need by pursuing the type of disruptive innovation we believe garadacimab represents.”

A genetic and fatal condition, HAE leads to painful episodes of swelling of the abdomen, larynx, and face, among other areas.

Apart from HAE, the company is analysing garadacimab for various indications such as pulmonary fibrosis, where hindering FXIIa could have a crucial role in boosting clinical outcomes.