AstraZeneca’s Great Weekend—Positive Results in Two Trials

AstraZeneca had a big weekend, with positive results from two separate clinical trial programs causing stock to jump 3.4%. First, the company reported positive results from its Phase III THEMIS clinical trial of Brilinta (ticagrelor) plus aspirin for cardiovascular (CV) death, heart attack, or stroke. Compared to aspirin alone, the combination decreases these risks by 10%.

The THEMIS trial population was patients with coronary artery disease (CAD) and type 2 diabetes (T2D) with no previous heart attack or stroke. The trial also had a sub-analysis of patients who had already had a percutaneous coronary intervention (PCI), which is a procedure used to open a blocked or narrowed coronary artery. In this analysis of this group, there was a 15% relative risk reduction compared to aspirin alone.

“These positive results show that Brilinta reduced the risk of cardiovascular events in patients with coronary artery disease and type 2 diabetes, and we hope this will make a difference because their risk of heart attack or stroke is almost twice as high as it is among diabetes patients without cardiovascular disease,” said Mene Pangalos, AstraZeneca’s executive vice president, BioPharmaceuticals R&D. “Also, for the first time, these new data identified an easily-recognizable sub-group of stable patients who may benefit most from Brilinta—those with type 2 diabetes who have undergone PCI.”

Brilinta is an oral, reversible, direct-acting P2Y12 receptor antagonist. It inhibits platelet activation. It is indicated with aspirin to prevent atherothrombotic events in adults with ACS or in patients with a history of myocardial infarction and a high risk of developing an atherothrombotic event.

Secondly, the company also reported data from a study of its diabetes drug Farxiga (dapagliflozin) that showed it reduced mortality rates or worsening of heart failure by 26% in patients who had previously had reduced ejection fraction heart failure. The results from the Phase III DAPA-HF was the first outcomes trial with an SGLT2 inhibitor looking at heart failure in patients with reduced ejection fraction (HFrEF) with or without type 2 diabetes. The detailed results were presented as the ESC Congress 2019 in Paris.

“We are very pleased that Farxiga was so effective in our trial—it did all the things we would like any drug to do in heart failure, which are to improve symptoms, reduce hospital admissions and increase survival,” stated John McMurray, University of Glasgow, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences. “Even better, Farxiga was as effective in heart failure patients without diabetes as in those with diabetes.”

The dual positive news pleased investors, driving company shares 3.4% higher. Analysts at Deutsche Bank dubbed the results “exceptionally impressive” and expect Farxiga will become the new standard of care for heart failure in patients with or without diabetes. “We believe this represents an addition [$1 billion-$4 billion] market opportunity for the class, which is not reflected in consensus forecasts,” the analysts indicated.

Citi analysts called the efficacy and safety data “stellar” and believed that in the reduced ejection fraction heart failure population the drug will gain quick market access.

Ruud Dobber, AstraZeneca’s executive vice president and president BioPharmaceuticals said that Farxiga’s cardiovascular benefits was a bit of a lucky coincidence. Because many diabetes drugs have cardiac complications, regulators required AstraZeneca to run a cardiovascular safety trial to ensure that the drug wasn’t dangerous. The trial not only showed that the drug was safe, but that it actually improved heart function.