Eli Lilly and Boehringer Ingelheim are gunning for a heart-failure nod for diabetes drug Jardiance. And if they can get it, they want to be able to talk up the product’s effects on exercise ability, too.
On Tuesday, the partners said they would expand their clinical trial lineup for Jardiance with the addition of two phase 3 studies designed to evaluate the impact of 12 weeks of Jardiance treatment in heart failure patients. Both studies, set to enroll about 300 patients and wrap in 2019, will pit the therapy against placebo and look at how well it can reduce heart failure symptoms and increase patients’ exercise capacity, as measured by a six-minute walk test.
If all goes well, Lilly and BI can begin carving out a niche for the drug within the current lineup of heart failure options. "There are limited treatment options that can help improve the everyday lives of people living with chronic heart failure,” Jeff Emmick, M.D., Ph.D., Lilly’s VP of diabetes product development, said in a statement. "We look forward to seeing whether Jardiance can help address this unmet need."
But it’s not necessarily just the current lineup of heart failure options that the companies will have to worry about if they do enter the space. Jardiance’s fellow SGLT2 therapies, Johnson & Johnson’s Invokana and AstraZeneca’s Farxiga, could eventually join it.
Lilly and Boehringer, though, will have the head start, thanks to the 2015 finding that Jardiance could cut the combined risk of heart attack, stroke and cardiovascular death by 14% in high-risk Type 2 diabetes patients. It was the first such finding for a diabetes drug, and it led the duo to launch heart failure outcomes trials last month in patients both with and without diabetes.
But Invokana has since then shown that it, too, could improve CV outcomes, and even AstraZeneca—which is still awaiting outcomes data for Farxiga—has launched heart failure studies in the hopes of uncovering a classwide effect.
Lilly and BI, though, trumpeted their lead in the space on Tuesday, noting that the new studies were “part of the most comprehensive clinical trial program of an SGLT2 inhibitor in chronic heart failure.”