DARE-19 Phase III trial for Farxiga in COVID-19 misses endpoint

Disappointing high-level results of the primary analysis from the DARE-19 Phase III trial assessing the potential of diabetes drug Farxiga (dapagliflozin) to treat patients hospitalized with COVID-19 who are at risk of developing serious complications have been released by UK pharma major AstraZeneca (LSE: AZN).

The trial did not achieve statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days. The study was conducted in partnership with Saint Luke’s Mid America Heart Institute.

DARE-19 was the first Phase III trial to evaluate the safety and efficacy of a sodium-glucose co-transporter-2 (SGLT2) inhibitor in patients hospitalized with COVID-19 who also have risk factors for developing serious complications, including hypertension (HTN), type-2 diabetes (T2D), atherosclerotic cardiovascular disease (ASCVD), heart failure (HF) or chronic kidney disease (CKD) Stages 3-4. Cardiac, renal and metabolic co-morbidities have been associated with poor outcomes and death in patients hospitalized with COVID-19.