Innovent has scored another phase 3 win for mazdutide as the drug showed its superiority to Eli Lilly's diabetes and heart drug Trulicity when it came to glycemic control in patients with Type 2 diabetes.
China-based Innovent secured the rights to mazdutide from Lilly back in 2019 for an undisclosed sum. Innovent kicked off this year showing success in a weight loss study that the company declared as demonstrating the drug is “the first GLP-1R/GCGR dual agonist succeeding in phase 3 trials.”
That success seems to have continued into the DREAMS-2 trial, which enrolled 731 patients in China with Type 2 diabetes, who received either 4-mg or 6-mg doses of mazdutide or 1.5 mg of Lilly’s own approved diabetes drug Trulicity.
After 28 weeks of treatment, patients in both the mazdutide cohorts showed improved glycated hemoglobin (HbA1c) levels when compared to those on Trulicity, hitting the trial’s primary endpoint.
The key secondary endpoints also showed mazdutide's superior benefits in terms of the proportion of patients who saw weight loss of more than 5% and those whose HbA1c levels was less than 7%, Innovent explained in the May 8 postmarket release.
While gastrointestinal reactions were the most common adverse events, most of these cases were mild to moderate in severity, mainly occurring during the first 12-week titration period, the biotech explained.
Data from DREAMS-2 will go toward the ongoing review of mazdutide by Chinese regulators for weight management, Innovent said. A similar study, DREAMS-1, is due to read out in mid-2024, after which the company will also apply to the regulator for mazdutide’s approval as a diabetes treatment.
“In the DREAMS-2 study, mazdutide showed comprehensive superiority to dulaglutide, one of the most-described glucose-lowering drugs in the world,” Lei Qian, M.D., Ph.D., vice president of clinical development of Innovent, said in the release.
“We will further analyze the study data, and strive to submit an NDA for T2D as soon as possible this year, so as to help more Chinese T2D patients to achieve target blood glucose levels and acquire metabolic benefits,” he added. “At the same time, we look forward to the performance of mazdutide in the DREAMS-3 study, a head-to-head study with semaglutide."
Lilly has the rights to develop mazdutide outside of China and continues to list the candidate in its phase 2 pipeline as a treatment for obesity.
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