Eli Lilly (NYSE:LLY) today announced positive safety and efficacy data for its investigational once-weekly insulin efsitora alfa (efsitora).
The QWINT-1, QWINT-3 and QWINT-4 Phase 3 clinical trials evaluated efsitora in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively.
In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. The company now plans to submit the once-weekly insulin for adults with type 2 diabetes to global regulatory agencies by the end of this year.
Lilly reported the presentation of the study results at the American Diabetes Association’s 85th Scientific Sessions in Chicago. Simultaneously, results from QWINT-1, a first-of-its-kind fixed-dose study, were published in The New England Journal of Medicine. The other two studies were published in The Lancet.
A look at the results from Lilly
In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52. Study investigators titrated efsitora to four fixed doses at four-week intervals, as needed for blood glucose control. In QWINT-3, it reduced A1C by 0.86%, compared to 0.75% for insulin degludec at week 26. Finally, in QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26. These trials featured traditional insulin dosing methods with adjustments based on each patient’s glucose level.
All three trials recorded a safety profile similar to two of the most commonly used daily basal insulin therapies for type 2 diabetes. In QWINT-1, it resulted in approximately 40% fewer hypoglycemic events compared to insulin glargine. That study recorded estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.50 with efsitora vs. 0.88 with insulin glargine at 52 weeks.
For QWINT-3, the rates came in at 0.84 with efsitora vs. 0.74 with insulin degludec at 78 weeks. In QWINT-4, estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 6.6 with efsitora vs. 5.9 with insulin glargine at 26 weeks.
“Building on Lilly’s legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year,” said Dr. Jeff Emmick, SVP of product development at Lilly. “These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach. We look forward to working with regulatory agencies to bring this innovation to patients around the world.”
