AstraZeneca’s Farxiga falls short in Phase III trials for treatment of COVID-19

AstraZeneca’s Farxiga drug, usually used in patients with diabetes, did not show statistical significance in the Phase III trial into its effects in people hospitalised with COVID-19.

The treatment did not reach its primary endpoints of achieving significant prevention of organ dysfunction and all-cause mortality, nor did it show a substantial change in clinical status at 30 days.

The Phase III DARE-19 study was the first to evaluate the safety and efficacy of a SGLT2 inhibitor in patients hospitalised with COVID-19, who also have risk factors for developing serious complications including hypertension, Type 2 diabetes, and heart failure. 

The placebo-controlled trial, which involved 1,250 participants, took place after cardiac, renal and metabolic comorbidities have been associated with poor outcomes and death in patients hospitalised with the virus.

Despite not reaching its primary endpoint in the study, the safety and tolerability profile for Farxiga at 30 days was consistent with the well-established safety profile of the medicine.

Dr Mikhail N Kosiborod, Cardiologist at Saint Luke’s Mid America Heart Institute, and Principal Investigator of DARE-19, said: “DARE-19 provided important data on the potential benefits and risks of using SGLT2 inhibitors to treat hospitalised patients with COVID-19. 

“While the trial did not achieve statistical significance, the findings are very interesting and valuable, and will inform future clinical science. Also, of importance, we learned that dapagliflozin’s [Farxiga’s] well-established safety profile was consistent in DARE-19.”

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, added: “Prior to the DARE-19 Phase III trial, there was little data on the use of SGLT2 inhibitors in hospitalised patients with COVID-19 and we have now helped to fill this knowledge gap. We look forward to the efficacy and safety data being presented in the coming weeks.”

Jack Goddard