BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions

• Phase 2 data highlights best-in-class potential of dual GLP-1R/GIPR agonist BGM0504 for weight management and metabolic risk reduction in individuals with type 2 diabetes and overweight, non-obese individuals
• Preclinical data for BGM1812 supports further development as next-generation amylin analog for obesity treatment

SUZHOU, China, June 23, 2025 /CNW/ -- BrightGene Pharmaceutical Co., Ltd., an international, innovation-driven pharmaceutical company, presented data from two Phase 2 studies for BGM0504, its investigational dual agonist targeting glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR), along with preclinical data for its novel amylin analog, BGM1812, at the 85^th Scientific Conference of the American Diabetes Association (ADA).

Results from two separate Phase 2 studies in BGM0504 demonstrated significant potential for weight management and metabolic risk reduction in individuals with type 2 diabetes (including superiority to semaglutide), and in overweight and obese non-diabetic individuals, respectively. Preclinical data for BGM1812 demonstrated superior receptor activation, robust weight loss and synergistic potential with GLP-1/GIP dual agonism, supporting its development as a next-generation amylin analog for obesity treatment.

"These Phase 2 data highlight the significant, best-in-class potential of BGM0504 as a treatment for type 2 diabetes and obesity, including potential superiority to semaglutide and a strong safety profile, while our preclinical data for BGM1812 support its continued development as a next-generation amylin analog for obesity treatment, underscoring the additional promise in our pipeline," said Dr. Jiandong Yuan, CEO, BrightGene. "Building on our extensive peptide expertise and strong heritage in high-quality, efficient drug development, BrightGene is committed to accelerating innovative therapeutics to help address unmet patient needs in metabolic disease and other important therapeutic areas."

BGM0504 Phase 2 Study in Type 2 Diabetes

This multicenter, randomized, double-blind (placebo-controlled) and open-label (semaglutide positive-controlled) evaluated the pharmacokinetics, safety and efficacy of once-weekly subcutaneous injection of BGM0504 across the primary endpoint, change from baseline in HbA1c at Week 12 of target dose administration, and multiple secondary endpoints including PPG-2h, FPG, body weight, HbA1c and combined HbA1c/body weight targets proportions, HOMA2-B, blood lipids, systolic blood pressure (SBP) and diastolic blood pressure (DBP).

The study enrolled 67 participants with type 2 diabetes between the ages of 18 and 65, 64 received dose after randomization, randomized into five groups: 5mg (n=13), 10mg (n=12), 15mg (n=13), positive-control group (semaglutide; n=16) or placebo (n=13). Enrolled participants included adults with a baseline HbA1c between 7.0% and 10.0%, and a body mass index (BMI) between 19.5 and 35 kg/m².

At Week 12 of target dose administration, treatment with BGM0504 resulted in reductions in HbA1c across the three dose groups that were statistically significant compared with the placebo group and greater than treatment with semaglutide, including -1.72% in the 5mg dose group, -1.94% in the 10mg dose group, and -2.48% in 15mg dose group, compared to -1.43% in semaglutide and -0.28% in placebo. Similar results were observed in multiple secondary endpoints, including PPG-2h, FPG, body weight, and HbA1c and combined HbA1c/body weight target proportions, while varying improvement trends were observed in HOMA2-B, blood lipids, SBP and DBP. Most treatment emergent adverse events (TEAEs) were Grade 1 or 2 during the rapid titration stage and gradually tolerated after reaching the target dose. The most common treatment-related gastrointestinal AEs were diarrhea, nausea and abdominal distension; no hypoglycemic or other unexpected adverse reactions occurred.

BGM0504 Phase 2 Study in Obesity

This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of BGM0504 in 120 Chinese adults with obesity during multiple-dose administration (subcutaneous injection). Enrolled participants included adults with a BMI ≥ 24kg/m² (mean BMI at enrollment ≥ 27kg/m²) with prediabetes and/or at least one obesity-related comorbidity, or adults with obesity (BMI≥ 28kg/m2, mean BMI at enrollment ≥ 30kg/m2). Participants were randomized into four groups: 5 mg (n=30), 10 mg (n=30), 15 mg(n=30), or placebo (n=30). The study consisted of a titration phase (2-6 weeks), 24-week treatment with once-weekly dosing, and a 2-week follow-up.

Study results demonstrated reductions in waist circumference ranging from −8.0 cm to −12.98 cm (p < 0.001), and significant weight reductions ranging from -10.77% to 19.78% (LS means, placebo adjusted). Results also showed improvements in systolic blood pressure ranging from −11.60 to −13.03 mmHg and diastolic blood pressure ranging from −5.98 to −7.50 mmHg (p < 0.05).

Secondary outcomes further supported the efficacy of BGM0504, and all doses were well tolerated with common adverse events.

BGM1812 Preclinical Study

In a preclinical study, BGM1812 demonstrated strong receptor activation with 1.8× and 2.2× increased agonist activity (EC50) at the amylin and calcitonin receptors, respectively, versus petrelintide. The agonist also demonstrated dose-dependent weight loss in 0.012 - 0.12 mg/kg dose range in the diet-induced obese (DIO) rat model.

At 0.04 mg/kg, BGM1812 achieved greater weight reduction than petrelintide. In addition, BGM1812 significantly preserved relative lean mass while reducing relative fat mass. Additionally, the combination of BGM1812 and BGM0504 resulted in greater and more sustained weight loss than either semaglutide+cagrilintide or amycretin in the DIO rat model.

About BGM0504

The peptide hypoglycemic drug BGM0504 injection is a dual agonist of GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors independently developed by BrightGene. BGM0504 can stimulate the downstream pathways of GIP and GLP-1, produce biological effects such as controlling blood sugar, reducing weight and treating non-alcoholic steatohepatitis (NASH), and show potential for the treatment of various metabolic diseases. BGM0504 is currently in Phase 3 trials in China for weight management and type 2 diabetes and has completed a Phase 1 bridging study for weight management in the U.S. To date, BGM0504 has been investigated in more than 1,000 patients and demonstrated superior efficacy and a strong safety profile.

About BGM1812

BGM1812 is a novel amylin analog designed using AI/ML-driven optimization to enhance agonist activities and formulation properties. A potent and ultra long-acting amylin, BGM1812 has the potential to be a once weekly oral tablet.

About BrightGene

BrightGene is an international, innovation-driven pharmaceutical company, listed on the Shanghai Stock Exchange, dedicated to developing and manufacturing high-quality therapeutics to address unmet patient needs. Founded in 2001, BrightGene has evolved from an established global leader in high-hurdle generics and biosimilars to developing innovative metabolic and respiratory therapeutics. An established leader in challenging chemistry and conjugation, BrightGene has proprietary, cutting-edge platforms in peptides, siRNA, nanobodies, as well as advanced formulations, and 272 patents. The company remains a global supplier of 15 APIs and 2 drug products to the US and EU. BrightGene is headquartered in China. Additional information is available at https://www.bright-gene.com/.

SOURCE Bright Gene

Cecilia Hu, [email protected]