AstraZeneca, in alliance with Saint Luke’s Mid America Heart Institute, has started a Phase III clinical trial of its diabetes drug Farxiga (dapagliflozin) to treat hospitalised Covid-19 patients at risk of serious complications.
Farxiga is an oral, once-daily sodium-glucose transport protein 2 (SGLT2) inhibitor indicated for adults with insufficiently controlled type 2 diabetes (T2D), as an adjunct to diet and exercise.
Apart from glycaemic control, the drug works to reduce weight and blood pressure.
Data from the DECLARE CV outcomes trial in adult T2D patients showed that Farxiga decreased the risk of the composite endpoint of hospitalisation for heart failure or cardiovascular (CV) death compared to placebo when added to standard of care.
The new randomised, global trial, named DARE-19, will evaluate the drug’s ability to reduce the risk of disease progression, clinical complications, and death from Covid-19 in patients with CV, metabolic or kidney risk factors.
The presence of CV, metabolic or kidney conditions have been linked to poor outcomes and death in Covid-19 patients.
According to the company, DARE-19 is based on data on Farxiga’s protective effect in heart failure patients with decreased ejection fraction (HFrEF), chronic kidney disease (CKD), or T2D.
The trial will enrol around 900 patients in the US and European countries with a high number of Covid-19 cases.
It will recruit adult hospitalised patients with a history of hypertension (HTN), atherosclerotic CV disease, heart failure with reduced or preserved ejection fraction, T2D, or CKD Stage III to IV.
The primary outcome is time to first occurrence of death due to any cause or new/worsened organ dysfunction during 30 days of follow-up.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “AstraZeneca is committed to finding new solutions to fight Covid-19 by investigating the application of our new and existing medicines.
“With the Phase III DARE-19 trial, we aim to test whether Farxiga can prevent serious complications, such as organ failure, in those patients with pre-existing health conditions, a critical goal when treating Covid-19.”
Earlier this month, AstraZeneca announced plans for a global clinical trial of Calquence (acalabrutinib) to treat cytokine storm that manifests in severely ill Covid-19 patients.