The randomised and global phase III study will evaluate the efficacy of Farxiga as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure.
The study will evaluate whether Farxiga, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, can minimise the risk of disease progression, clinical complications, and death due to COVID-19 in patients who also have cardiovascular (CV), metabolic or kidney risk factors.
Saint Luke’s Mid America Heart Institute cardiologist and DARE-19 study principal investigator Dr Mikhail Kosiborod said: “Dapagliflozin has demonstrated cardio and renal protective benefits and improved outcomes in high-risk patients with type-2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease.”
The design of the study is based on the data of Farxiga’s protective effect in patients with heart failure with reduced ejection fraction (HFrEF), chronic kidney disease (CKD) or type 2 diabetes (T2D).
The international, parallel-group double-blind, placebo-controlled and investigator-sponsored phase III trial will recruit up to 900 patients from the US and other European countries with a high COVID-19 impact.
According to the company, the study’s primary efficacy outcome is time to the first occurrence of death from any cause or new/worsened organ dysfunction through 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.”
Recently, AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Koselugo (selumetinib) to treat paediatric patients aged two years and older with neurofibromatosis type 1 (NF1) who have symptomatic and inoperable plexiform neurofibromas (PN).