Insulin Glargine(Samsung Bioepis Co., Ltd.)

Efsitora met the primary endpoint in both QWINT-2 and QWINT-4 with once-a-week dosing regimen for people living with type 2 diabetes Efsitora was equally safe and effective among adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists INDIANAPOLIS, May 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials evaluating once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes using insulin for the first time (insulin naïve) and those who require multiple daily insulin injections. In the treat-to-target clinical trials, efsitora showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally. "The results of QWINT-2 and QWINT-4 are a significant milestone for the diabetes community and demonstrate that efsitora as a weekly insulin provides blood sugar control equivalent to daily basal insulins," said Jeff Emmick, MD, Ph.D., senior vice president, product development, Lilly. "With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes." QWINT-2 evaluated the efficacy and safety of once-weekly efsitora compared to once-daily insulin degludec for 52 weeks. The trial randomized insulin-naïve adults with type 2 diabetes to receive efsitora once weekly or insulin degludec once daily and was also designed to assess efficacy in patients using and not using GLP-1 receptor agonists. The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 52. For the efficacy estimand1,2, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95% respectively3. In a key secondary endpoint, efsitora was non-inferior to insulin degludec in A1C change among participants using and not using GLP-1 receptor agonists. Further, participants taking efsitora spent 45 minutes more time in range4 and 37 minutes more in tight range5 without additional time in hypoglycemia (blood glucose <54 mg/dL) in comparison to insulin degludec. QWINT-4 evaluated the efficacy and safety of efsitora compared to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized participants to receive efsitora once weekly or insulin glargine once daily, both of which were administered with insulin lispro. The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 26. For the efficacy estimand, both efsitora and insulin glargine reduced A1C by 1.07% resulting in an A1C of 7.12% and 7.11%, respectively6,7. In both QWINT-2 and QWINT-4, efsitora was safe and well-tolerated with estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL) hypoglycemic events per patient-year of exposure of 0.58 with efsitora vs. 0.45 with insulin degludec (QWINT-2) and 6.6 with efsitora vs. 5.9 with insulin glargine (QWINT-4). Detailed results from QWINT-2 will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024. Topline readouts from QWINT-1, QWINT-3 and QWINT-5 are anticipated later this year. About the QWINT clinical trial program The QWINT phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 4,000 people living with type 1 or type 2 diabetes across five global registration studies. QWINT-2 (NCT05362058) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 928 participants across the U.S., Brazil, Canada, China, Czechia (Czech Republic), Germany, Greece, Japan, Korea, Mexico and Puerto Rico to receive efsitora once weekly or insulin degludec once daily administered subcutaneously. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to insulin degludec. The trial was also designed to assess efficacy and safety for patients using and not using GLP-1 receptor agonists. QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. About insulin efsitora alfa Insulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase 3 development for adults with type 1 and 2 diabetes. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about insulin efsitora alfa as a potential treatment for people with type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 2 diabetes, that insulin efsitora alfa will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 1 The efficacy estimand represents the treatment effect had all participants adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia. 2 95% CI for treatment difference (-0.22% to 0.061%). 3 From a baseline A1C of 8.21% for efsitora and 8.23% for insulin degludec. 4 Blood glucose 70-180 mg/dL. 5 Blood glucose 70-140 mg/dL. 6 From a baseline A1C of 8.18% for efsitora and insulin glargine. 7 95% CI for treatment difference (-0.13% to 0.14%). SOURCE Eli Lilly and Company

New data readouts from Eli Lilly tick off two of the five upcoming efsitora R&D milestones. Eli Lilly finds itself in a familiar position: snapping at the heels of Novo Nordisk. The Indianapolis-based drugmaker kept itself in the slipstream of its regular foe Thursday with positive top-line data from a pair of phase 3 studies of its once-weekly insulin candidate. Lilly and Novo have identified once-weekly basal insulin as a way to slash the burdens on some people with diabetes. Rather than inject 365 daily doses each year, patients could administer 52 weekly shots. Novo is close to making that vision a reality for patients in the U.S., where a FDA advisory committee is set to discuss its filing for approval of Awiqli next week. Lilly is following close behind. Having revealed the top-line success of the QWINT-4 trial late last month, Lilly reported a primary endpoint hit on a second study, QWINT-2, and shared data from both trials Thursday. The studies are part of a five-trial program that is testing Lilly’s basal insulin fusion protein and is nearing completion.  QWINT-2 compared Lilly’s once-weekly insulin efsitora alfa to the daily insulin degludec in almost 1,000 adults with Type 2 diabetes who were starting basal dosing for the first time. After 52 weeks, efsitora was noninferior to daily dosing, with the A1C measure of blood sugar falling 1.34% and 1.26%, respectively, in the investigational and control arms.  Lilly designed the study to assess whether the use of GLP-1 receptor agonists, such as its own Mounjaro and Novo’s Ozempic, affects the efficacy of efsitora. It turns out that the once-weekly formulation was noninferior to daily dosing in the GLP-1 subgroup. Patients on efsitora spent 45 minutes more time in range and 37 minutes more in tight range without additional time in hypoglycemia in comparison to their peers on daily doses.  QWINT-4 enrolled adults with Type 2 diabetes who had previously been treated with basal insulin and at least two injections per day of mealtime insulin. After 26 weeks, efsitora was noninferior to daily insulin glargine on the primary endpoint of A1C. The measure of blood sugar fell 1.07% in both cohorts.  Lilly said efsitora was safe and well tolerated in both trials. The rates of severe or clinically significant low blood glucose events per patient year of exposure were numerically higher in the efsitora cohorts. In QWINT-2, the figures were 0.58 and 0.45, respectively, in the weekly and daily arms. QWINT-4 tracked rates of 6.6 in the efsitora arm and 5.9 in the control group. The readouts tick off two of the five upcoming efsitora R&D milestones. Lilly’s remaining three phase 3 trials, which are assessing efsitora in various Type 1 and Type 2 populations, have completion dates in May and July. The drugmaker plans to report top-line data from the three studies later this year.