Announcement • Jun 13
Gan & Lee Pharmaceuticals Reports Positive Clinical Results for Insulin Ludefen and Bofanglutide
Gan & Lee Pharmaceuticals announced that two of its core pipeline products in the fields of diabetes and obesity treatment have recently achieved positive clinical results. Insulin Ludefen is an investigational ultra-long-acting once-weekly basal insulin analog independently developed by Gan & Lee Pharmaceuticals. The drug's pivotal Phase III clinical trial in China, SUPER-3, recently met its pre-specified primary endpoint. SUPER-3 is a 26-week, treat-to-target, Phase 3 clinical trial conducted at 80 medical sites across China. The study enrolled 596 adults with type 2 diabetes (T2DM) who had previously been treated with basal-bolus insulin, premixed insulin analogs or dual insulin analog. It evaluated once-weekly Insulin Ludefen compared with once-daily insulin glargine U100 (Lantus®) injection, both in combination with insulin aspart, with or without non-insulin antidiabetic agents. The study met its primary endpoint. In patients with T2DM previously treated with mealtime insulin aspart, premixed insulin analogs, or dual insulin analogs, once-weekly Insulin Ludefen, used as the basal insulin component in combination with prandial insulin aspart, demonstrated superior HbA1c reduction versus once-daily insulin glargine U100. After 26 weeks of treatment, compared with the once-daily glargine insulin U100 regimen, the once-weekly Insulin Ludefen demonstrated superiority in reducing HbA1c levels (change from baseline: -1.58% vs. -1.41%); the estimated between-group treatment difference was -0.17%, and this difference was statistically significant (p=0.0021, GLP-1 RAs. The most common adverse events were gastrointestinal reactions and were mostly mild to moderate and transient, with no new safety signals identified. The above topline results were based on analyses of the modified intention-to-treat (mITT) population and the safety set (SS). Meanwhile, a Phase 2 clinical trial evaluating the efficacy and safety of bofanglutide injection in overweight and obese participants in the United States has also met its primary endpoint. This Phase 2 clinical study was a multicenter, randomized, controlled study that enrolled a total of 326 participants across 20 clinical trial sites in the United States. Bofanglutide injection and placebo were administered under double-blind conditions, while tirzepatide injection served as an open-label comparator. The study evaluated the efficacy and safety of bofanglutide injection in adult participants who had inadequate weight control despite lifestyle interventions and had either a BMI > 30 kg/m², or a BMI = 27 kg/m² accompanied by weight-related comorbidities (excluding type 2 diabetes). Participants were randomized to receive bofanglutide injection 24 mg, 36 mg, or 48 mg Second Quarter or placebo, or 15 mg of tirzepatide injection once weekly for 36 weeks (including a dose-escalation phase). After 36 weeks of treatment, among participants with overweight/obesity without type 2 diabetes, the 48 mg bofanglutide injection group achieved an average weight loss of 15.18%, with no weight loss plateau observed; the 15 mg tirzepatide injection group achieved a mean weight reduction of 16.93%. Bofanglutide injection also demonstrated significant improvements in cardiovascular and metabolic parameters, including blood pressure, waist circumference, and serum uric acid levels. The most common adverse events were gastrointestinal in nature, including nausea, vomiting, and diarrhea; these events were generally mild and transient, and no new safety signals were identified. The above top-line results are based on analyses of the Per-Protocol set (PPS). The Insulin Ludefen SUPER-8 study (a head-to-head comparison with insulin icodec) and other studies in the GRADUAL clinical program of bofanglutide injection are currently underway. Detailed results from these two studies are scheduled to be presented at future scientific conferences and published in international academic journals.
