Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase III DREAMS-2 study for mazdutide (IBI362), a dual agonist targeting both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), has met its primary endpoint in Chinese subjects with type 2 diabetes (T2D). The study results indicate that mazdutide demonstrated superior glycemic control compared to dulaglutide, a current standard of care.
The multi-center, randomized Phase III clinical study, DREAMS-2 (ClinicalTrials.gov, NCT05606913), aimed to evaluate the efficacy and safety of mazdutide against dulaglutide in T2D patients with inadequate glycemic control despite metformin monotherapy or combination therapy with other oral drugs. The trial enrolled 731 subjects who received either mazdutide at 4.0 mg or 6.0 mg, or dulaglutide at 1.5 mg for 28 weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) levels from baseline to week 28.
After 28 weeks, both doses of mazdutide showed non-inferiority to dulaglutide in improving HbA1c levels. Superiority was further established for both doses of mazdutide over dulaglutide in various endpoints, including HbA1c reduction, weight loss, and the proportion of subjects achieving HbA1c levels below 7.0%. Mazdutide also exhibited a favorable safety profile, with no new safety signals identified.
Innovent has partnered with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (mazdutide) in China. The drug’s recent clinical data suggest it has the potential to be a best-in-class treatment for both T2D and obesity. Mazdutide was filed for the first approval for chronic weight management in adults with obesity or overweight in February 2024. The results of the DREAMS-1 study, another Phase III trial, are anticipated this year, with a second New Drug Application (NDA) filing for T2D expected with the Center for Drug Evaluation (CDE).- Flcube.com
