Sciwind Biosciences Co., Ltd, a China-based pharmaceutical company, has released the latest topline Phase III data for its lead anti-obesity candidate, ecnolgutide (XW003), in the treatment of type 2 diabetes mellitus (T2DM), following positive Phase II results for the drug as an obesity treatment released in June 2023.
The randomized, double-blind, placebo-controlled trial (NCT05680155) is conducted across 33 sites in China, enrolling 211 participants with T2DM. Ecnolgutide was administered at 0.6mg or 1.2mg dosages once per week for 24 weeks. The HbA1c reductions from baseline were 1.96% and 2.43% for the drug, compared to 0.87% for the placebo. Weight loss from baseline was -4.51% and -4.74% for the drug, respectively, versus -2.02% for the placebo. In the 1.2mg group, 76.1% of participants achieved HbA1c ≤ 6.5%, and 35.2% achieved HbA1c < 5.7% at the end of the treatment period.
Sciwind CEO Hai Pan described the results as “very promising” and “comparable to the treatment effects seen with dual GLP-1/GIP analogs such as tirzepatide”. The drug was well-tolerated, with gastrointestinal adverse events consistent with established GLP-1 receptor agonists. Ecnolgutide is a novel, cAMP signaling biased, long-acting GLP-1 analogue optimized for improved biological activity, cost-effective manufacturing, and once-weekly dosing.- Flcube.com