Eli Lilly’s efsitora alfa, which is meant to be taken weekly instead of multiple times a day, demonstrated non-inferior A1C reduction in a Phase III trial compared to Novo Nordisk’s daily insulin.
The insulin race between Eli Lilly and Novo Nordisk is heating up. The Indiana-based pharma announced positive Phase III results Thursday for its weekly insulin injection, efsitora alfa (efsitora), against Novo’s daily insulin product in adults with type 2 diabetes.
The Qwint-2 trial investigated the efficacy and safety of the once-weekly insulin against Novo Nordisk’s once-a-day degludec, marketed as Tresiba, for 52 weeks. The late-stage study reached the primary endpoint of non-inferior A1C reduction, with the results showing that efsitora reduced A1C by 1.34% compared to 1.26% for degludec. Results also showed an A1C level of 6.87% in efsitora patients, while those on degludec had an A1C of 6.95%.
Lilly’s efsitora results come as Novo is looking to get across the finish line with its own weekly insulin Icodec. Novo’s weekly insulin is slated to go in front of an FDA advisory committee on May 24 and has already demonstrated a non-inferior result versus Sanofi’s insulin glargine, marketed as Lantus, and degludec.
In 2022, Novo showed that when put up against glargine, Icodec had a reduction in HbA1c levels and had more time in the target blood sugar range. When compared to Novo’s insulin, Icodec reduced HbA1c by -0.47% compared to -0.51% for degludec.
On Thursday, Lilly also released data for the Qwint-4 trial which compared efsitora to glargine, hitting the primary endpoint of non-inferior A1C reduction. At week 26, the study showed efsitora and glargine reduced A1C by 1.07% resulting in an A1C of 7.12% and 7.11%, respectively.
“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,” Jeff Emmick, senior vice president of product development at Lilly, said in a statement.
Lilly reported that efsitora was safe and well tolerated in both trials. However, there were higher rates of severe or clinically significant hypoglycemic events per year: 0.58 in efsitora patients versus 0.45 in those taking degludec and 6.6 in those on efsitora compared to 5.9 in glargine patients.
The company said it will provide more details about the Qwint-2 trial at the European Association for the Study of Diabetes (EASD) annual meeting in September 2024, and expects topline results from the Qwint-1, Qwint-3, and Qwint-5 trials later this year.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
