Benzinga | May 17, 2021 07:43AM EDT

AstraZeneca's Farxiga Flunks Late-Stage COVID-19 Study

* AstraZeneca plc (NASDAQ: AZN) presented detailed data from the DARE-19 Phase 3 trial at the American College of Cardiology, evaluating Farxiga (dapagliflozin) to treat hospitalized COVID-19 patients who are at risk of developing serious complications.

* 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 at 30 days.

* The Phase 3 trial had enrolled 1,250 hospitalized pandemic patients with underlying conditions. For 30 days, patients were treated daily with either a placebo or dapagliflozin, and they continued that routine regardless of disease progression.

* Researchers found that 11.2% of dapagliflozin patients died or suffered organ failure - one of the study's primary endpoints, compared with 13.8% of placebo patients.

* During the study follow-up, 6.6% of patients in the dapagliflozin group died versus 8.6% in the placebo group. The secondary endpoint of recovery, mostly measured as time to hospital discharge, was similar between the two groups.

* Despite the failure, it was observed that patients on Farxiga posted numerically fewer serious side effects than placebo in DARE-19 with two non-severe cases of diabetic ketoacidosis observed, both in the Farxiga arm and in patients with prior history of Type 2 diabetes.

* In the Farxiga arm, there were 21 reports of kidney injury compared with 34 in the placebo group. Meanwhile, there were two reports of ketoacidosis among the Farxiga group compared with none in the placebo arm.

* See the ACC presentation here.

* Price Action: AZN shares are trading 0.40% higher at $55.43 during the premarket session on the last check Monday.