Shortly after a positive data drop for Eli Lilly’s efsitora alfa, the Indianapolis-based company is again padding the case for its weekly insulin prospect.
Tuesday, Lilly revealed that efsitora met its primary endpoints for reducing the A1C measure of blood sugar across two more trials in the company's five-study QWINT phase 3 development program.
Lilly published the data from the trials, QWINT-2 and QWINT-5, in The New England Journal of Medicine and The Lancet, respectively. The company also presented the results this week at the annual meeting of the European Association for the Study of Diabetes in Spain.
The latest readouts “build upon the positive topline results we shared from our QWINT-1 and QWINT-3 trials last week, and from our QWINT-4 trial in May,” Paul Owens, vice president of global brand development for insulins and glucagon at Lilly, said in an interview.
“The results we’ve shared from the collective QWINT phase 3 trials add to a growing body of evidence that really supports efsitora and the potential for once-weekly insulin to transform the treatment options for people with Type 2 diabetes and some with Type 1 diabetes," Owens continued.
Taking a closer look at QWINT-2—which pitted efsitora against daily insulin degludec in adults with Type 2 diabetes using insulin for the first time—Lilly’s prospect met its primary goal by showing a non-inferior average A1C reduction. On the primary measure, Efsitora cut patients’ A1C by an average of 1.34% compared to 1.26% for the degludec cohort, resulting in an overall average A1C levels of 6.87% and 6.95%, respectively. The trial ran for 52 weeks.
Moreover, patients on efsitora achieved 45 minutes more time in a target blood glucose range—without additional time in hypoglycemia—versus insulin degludec, Lilly said in a release.
Efsitora’s safety profile largely matched that of degludec in the trial, Lilly said, noting that there were no severe low blood sugar events reported by patients on efsitora. Six hypoglycemia events were reported in the study’s daily insulin arm.
As for QWINT-5, which compared efsitora to daily insulin degludec in Type 1 diabetes patients who need daily basal injection and multiple mealtime doses, Lilly’s long-acting prospect lowered A1C by 0.53% on average versus 0.59% for degludec, according to the trial’s efficacy estimand.
Time in range—a key secondary endpoint in the study—was similar for patients on efsitora and degludec during the four weeks prior to the study’s 26-week mark, Lilly said in a separate release.
“Imagine 313 fewer injections per year,” Owens said during his interview, speaking to the promise of a once-a-week insulin for diabetes patients. “We believe it has the potential to really improve adherence … and for some the innovation of a simple, once weekly approach to dosing could really mean the difference between starting the treatment and not.”
Diabetes patients have been forced to dose insulin daily for nearly a century, the executive added, noting that daily injections in response to blood glucose tests can become a “huge burden” for those living with the metabolic disease.
While once-weekly insulin remains a “significant area of interest” for Lilly, the company has not yet submitted the data on efsitora for regulatory review, Owens said. He stressed that the company “can’t speculate on any potential timelines for those discussions.”
Lilly unveiled its latest slate of efsitora data after dropping positive readouts from the med’s QWINT-1 and QWINT-3 trials last week.
As with the latest clutch of results, efsitora met its primary endpoints in both studies by achieving noninferior A1C reductions when put up against two common daily insulins.
The positive momentum for Lilly’s weekly insulin candidate comes after its chief metabolic rival, Novo Nordisk, suffered a recent setback for its own weekly prospect, insulin icodec, in the U.S.
In July, the FDA rejected Novo’s product—which is approved as Awiqli in Europe, Canada, Japan and Australia—over manufacturing issues and questions tied to the drug’s potential Type 1 diabetes indication. That same month, Novo said it didn’t expect to resolve the regulatory issues on insulin icodec before the end of 2024.