Innovent Biologics has recently achieved a significant milestone in the development of its drug mazdutide, marking another phase 3 triumph. This comes as particularly good news for patients with Type 2 diabetes, as mazdutide has demonstrated superior glycemic control compared to Eli Lilly’s Trulicity, a well-established diabetes and heart disease medication.
Background of the DREAMS-2 Trial
The DREAMS-2 trial, a robust clinical study conducted by Innovent, enrolled 731 patients across China who have Type 2 diabetes. These participants were administered either 4 mg or 6 mg doses of mazdutide or a control dose of 1.5 mg of Trulicity. After 28 weeks of treatment, the results revealed that patients treated with mazdutide exhibited significantly improved glycated hemoglobin (HbA1c) levels compared to those who received Trulicity, thus achieving the primary endpoint of the trial.
Secondary Endpoints and Results
Beyond the primary measure of glycemic control, mazdutide also excelled in key secondary endpoints. A higher proportion of patients in the mazdutide groups experienced substantial weight loss (over 5%), and a greater number achieved HbA1c levels below 7%. These outcomes not only underscore mazdutide’s effectiveness in managing blood sugar levels but also its potential benefits in weight management for diabetic patients.
Safety Profile
Despite the promising efficacy outcomes, the trial did report gastrointestinal reactions as the most prevalent side effects. However, these were mostly mild to moderate in nature and primarily occurred during the initial 12-week titration period, suggesting they may be manageable within a clinical setting.
Regulatory and Future Steps
The positive results from the DREAMS-2 trial are set to support ongoing discussions with Chinese regulators regarding mazdutide’s approval for weight management. Furthermore, Innovent is preparing for the results of another critical study, DREAMS-1, expected in mid-2024. Success in this study could pave the way for mazdutide’s regulatory approval as a treatment for diabetes in China.
Dr. Lei Qian, Vice President of Clinical Development at Innovent, expressed optimism about the data, noting mazdutide’s comprehensive superiority over one of the globally most-prescribed glucose-lowering drugs. He emphasized the company’s commitment to advancing the regulatory submission for Type 2 Diabetes (T2D) within the year, aiming to broaden the therapeutic options available to diabetic patients in China.
Implications for Lilly and the Global Market
While Innovent holds the rights to develop and market mazdutide within China, Eli Lilly retains the rights to develop the drug for markets outside of China. Lilly lists mazdutide in its phase 2 pipeline as a potential treatment for obesity, indicating ongoing interest and investment in its global potential.
This development places mazdutide as a promising candidate in the increasingly competitive landscape of diabetes and obesity treatments, highlighting Innovent’s strategic capabilities in drug development and its potential impact on public health. As the clinical data continues to unfold, the medical community and potential patients eagerly anticipate further advancements.