- Results from three clinical studies show ecnoglutide to be safe and well-tolerated, and demonstrate robust therapeutic effects in overweight/obese and type 2 diabetes patients
- On-going Phase 3 clinical trials in Chinese patients with type 2 diabetes and obesity have achieved target enrollments
HANGZHOU, China and SAN FRANCISCO, June 24, 2023 /PRNewswire/ — Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease, today announced that the company will present positive results from clinical studies of ecnoglutide at the 83rd American Diabetes Association (ADA) conference. Three poster presentations, including one late-breaking poster presentation, will highlight the safety and efficacy of ecnoglutide in clinical studies in overweight/obese and type 2 diabetes populations. The ADA conference is being held in San Diego, CA, June 23-26, 2023.
Late Breaking Poster Presentation (79-LB): Saturday, June 24, 2023 from 11:30 AM – 12:30 PM
“An Open-label, Active-controlled Phase 2 Evaluation of Novel GLP-1 Analog Ecnoglutide (XW003) in Adults with Obesity”
This randomized, open-label, active controlled, Phase 2 study evaluated the effects of ecnoglutide compared to liraglutide on body weight reduction in adults with obesity. The trial, which was conducted in Australia and New Zealand, randomized participants to receive target doses of 1.2, 1.8, or 2.4 mg ecnoglutide as once-weekly subcutaneous injections or liraglutide (Saxenda®) at 3.0 mg as once-daily subcutaneous injections for 26 weeks, including up to 14 weeks of dose titration before reaching the target doses.
At 26 weeks, participants receiving 1.2, 1.8, or 2.4 mg weekly ecnoglutide achieved body weight reduction from baseline of -11.5%, -11.2%, and -14.7%, respectively, compared to -8.8% for those receiving 3.0 mg liraglutide daily injections (P<0.001 for the 2.4 mg dose group). The overall safety profile of ecnoglutide in this study was similar to other GLP-1 analogs.
Poster Presentation (755-P): Sunday, June 25, 2023 from 11:30 AM – 12:30 PM
“A Phase 2 Evaluation of a Novel GLP-1 Analog Ecnoglutide (XW003) for Glycemic Control in Adults with Type 2 Diabetes”
Ecnoglutide was evaluated in this randomized, double-blind, placebo controlled, Phase 2 trial in Chinese patients with type 2 diabetes. Participants received target doses of 0.4, 0.8, or 1.2 mg ecnoglutide or placebo as once-weekly subcutaneous injection for 20 weeks.
At 20 weeks, participants receiving ecnoglutide showed significant HbA1c reductions of -1.81 to -2.39% from baseline compared with -0.55% reduction for participants receiving placebo (P<0.0001). At end of treatment, up to 81% of participants receiving ecnoglutide achieved HbA1c <7% versus 19% for placebo and up to 33% had weight loss ≥5% from baseline versus 3% for placebo. Ecnoglutide was generally safe and well-tolerated in participants with type 2 diabetes. There were no treatment-related ≥Grade 3 AEs or SAEs.
Poster Presentation (756-P): Sunday, June 25, 2023 from 11:30 AM – 12:30 PM
“A Phase 1c Evaluation of a Novel GLP-1 Analog Ecnoglutide (XW003) for Weight Loss in Adults with Overweight and Obesity”
This randomized, double-blind, placebo-controlled study, which was conducted in China, enrolled 60 non-diabetic adults with overweight or obesity. Participants received 1.8 or 2.4 mg ecnoglutide or placebo as once weekly subcutaneous injections for 14 weeks, including a dose escalation period. The core treatment period was followed by a 12-week open-label extension for the ecnoglutide groups, for a total treatment duration of 26 weeks.
Ecnoglutide was safe and well-tolerated in this study. There were no study drug related SAEs or ≥ Grade 3 AEs. At 14 weeks, ecnoglutide led to significant weight reduction vs placebo (-8.9 to -9.5% vs 0.87%, P<0.0001). Weight loss continued during the open-label extension, reaching -13.2% to -15.0% at 26 weeks. At the end of extension period, 94.7% of participants in the 1.8 mg ecnoglutide cohort and 100% in the 2.4 mg ecnoglutide cohort achieved body weight reductions ≥5% from baseline. Significant changes were also noted in other weight-related parameters, including BMI, waist circumference, and waist-to-hip ratio.
Building on the positive results of these early phase clinical studies, Sciwind also announced that it began enrolling participants in Phase 3 clinical trials of ecnoglutide in China earlier this year. The trials are evaluating once weekly dosing of up to 2.4 mg ecnoglutide in adults with overweight or obesity, and dosing of up to 1.2 mg in type 2 diabetes patients. To date, these pivotal trials have achieved full target enrollments, and topline results are expected in 2024.
About ecnoglutide (XW003)
Glucagon-like peptide-1 (GLP-1) analogs are effective therapies in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for NASH. Ecnoglutide is a novel, biased, long-acting GLP-1 peptide analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing. Ecnoglutide has demonstrated treatment benefits for patients with type 2 diabetes and obesity and is safe and well tolerated in Phase 1 and Phase 2 clinical studies.
About Sciwind
Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Its product pipeline consists of potentially first-in-class and best-in-class drug candidates, including the long-acting GLP-1 peptide analog ecnoglutide (Phase 3), oral GLP-1 peptide analog XW004 (Phase 1), and oral small molecule GLP-1 receptor agonist XW014 (Phase 1). Sciwind has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutic delivery platforms and identified a series of drug candidates based on these core platform technologies. For more information, visit www.sciwindbio.com.
