Eli Lilly released two more sets of data for its once-weekly insulin efsitora a week after touting data from another two trials in its late-stage QWINT development program.
At the European Association for the Study of Diabetes (EASD) annual meeting in Madrid, Lilly presented data from the QWINT-2 and QWINT-5 studies.
In QWINT-2, efsitora met the primary endpoint of non-inferior A1C reduction in adults with type 2 diabetes using insulin for the first time. Efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec. The study also hit the secondary endpoint: Patients taking efsitora had 45 minutes more time in range each day. This dataset included about 50% of adults who were also on a GLP-1.
Lilly presented topline QWINT-2 data in May, along with topline results for QWINT-4, which also met its primary endpoint of non-inferior blood sugar reduction. This study included patients previously treated with basal insulin and at least two injections each day of mealtime insulin.
Molly Carr“There are several aspects of this molecule that are very, very innovative, where it’s very slow acting and a flat, slow release over time,” Molly Carr, head of clinical development for insulin at Lilly, told Endpoints News. “That’s really the most innovative thing about this insulin, is it’s more physiologic. It acts like your beta cell, more so than other basal insulins.”
Also presented at EASD on Tuesday were results from QWINT-5, which compared efsitora to insulin degludec in adults with type 1 diabetes who require daily basal and multiple daily mealtime insulin injections.
Again, the trial met the primary endpoint of non-inferior A1C reduction: efsitora reduced A1C by 0.53% compared to 0.59% for insulin degludec.
Carr told Endpoints News that the company does not disclose when it will file for approval with the FDA, but that the company is reviewing the positive data from the trials to prepare for registration.
Last week, Lilly dropped data from the Phase 3 QWINT-1 and QWINT-3 studies, which also met the primary endpoints of non-inferior A1C reduction compared with daily basal insulins.