Alexion Pharmaceuticals is set to enter the COVID-19 drug development race in the next few days via a single-arm, 100-patient Phase II trial investigating Soliris (eculizumab), a source familiar with the trial has revealed to GlobalData.
If this Phase II trial delivers a positive risk-benefit ratio, it would then pave the way for a 300-patient, randomised trial that would start shortly after. The Phase II trial will have sites in the US and Europe and is targeted to run for two weeks and the trial will have a primary endpoint looking into patient mortality between three-to-four weeks, the source said.