Forxiga trial starts to see if drug can prevent COVID-19 progression

By Editor
30th April 2020
Coronavirus, Pharmaceutical Research

The SGLT2 inhibitor dapagliflozin is being tested to see if it can help reduce COVID-19 progression, complications and death among adults with cardiovascular, metabolic or renal risk factors.

AstraZeneca, the company that makes Forxiga, has teamed up with the Saint Luke’s Mid America Heart Institute for the trial entitled DARE-19.

A total of 900 people across the US and Europe are being enrolled for the study which has been designed to see whether the drug can prevent organ failure among those infected with coronavirus.

Dr Mikhail Kosiborod, cardiologist at Saint Luke’s Mid America Heart Institute, professor of medicine at the University of Missouri-Kansas City School of Medicine and a principal investigator for DARE-19, said: “Patients with cardiometabolic conditions — atherosclerotic CVD, heart failure, hypertension, type 2 diabetes or CKD — are at substantially higher risk for morbid complications and death in the setting of COVID-19.

“Furthermore, the emerging data indicate that in addition to respiratory decompensation, cardiovascular and kidney related complications are common, and appear to be key drivers of poor outcomes.

“It thus follows that prevention of these complications in high-risk patients may lead to reduction in the disease severity and lower risk for morbid events and death. SGLT2 inhibitors have previously shown substantial cardio- and nephroprotective effects among patients with cardiometabolic conditions, and may provide target organ protection in the setting of COVID-19.”

Forxiga, which is known as Farxiga in America, is a first-in-class, oral, once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled type 2 diabetes as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction. In the DECLARE CV outcomes trial in adults with type 2 diabetes, the drug was found to reduce the risk of the composite endpoint of hospitalisation for HF or CV death versus placebo, when added to standard of care.

‘New solutions’

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, 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.”

Meanwhile, AstraZeneca has made an agreement with the University of Oxford to develop and manufacture a vaccine for coronavirus. Under the agreement, the company would be responsible for the development and worldwide manufacturing and distribution of the vaccine, known as ChAdOx1 nCov-19.

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “As COVID-19 continues its grip on the world, the need for a vaccine to defeat the virus is urgent. This collaboration brings together the University of Oxford’s world-class expertise in vaccinology and AstraZeneca’s global development, manufacturing and distribution capabilities. Our hope is that, by joining forces, we can accelerate the globalisation of a vaccine to combat the virus and protect people from the deadliest pandemic in a generation.”

The potential vaccine entered Phase I clinical trials last week to study safety and efficacy in healthy volunteers aged 18 to 55 years, across five trial centres in Southern England. Data from the Phase I trial could be available next month. Advancement to late-stage trials should take place by the middle of this year.

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