HANGZHOU, China and SAN FRANCISCO, Aug. 9, 2022 /PRNewswire/ -- Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, today announced positive interim topline results from a 26-week Phase 1c/2a clinical trial of XW003 (Ecnoglutide) in overweight or obese Chinese adult volunteers. XW003 is a novel, long-lasting glucagon-like peptide-1 (GLP-1) analogue that is being developed for the treatment of type 2 diabetes and obesity.
The Phase 1c/2a trial, which is being conducted in China, includes non-diabetic overweight or obese adult subjects. The trial consists of two parts: a randomized, double-blind, placebo-controlled 14-week core treatment phase (week 1-14; Part A), followed by an open-label extension phase in which participants will receive the study drug for an additional 12 weeks (week 15-26; Part B). The interim analysis was conducted after all participants completed the core treatment phase (Part A).
Eligible participants included healthy, non-diabetic subjects with a body mass index (BMI) between 24.0 and 35.0 kg/m2. Sixty subjects participated in the trial and were randomized to receive either 1.8 mg or 2.4 mg of XW003 or placebo once weekly as subcutaneous injections. For the XW003 cohorts, participants started the study at 0.3 mg and then dose titrated to their final randomized dose of 1.8 mg or 2.4 mg. At baseline, participants had a mean body weight of 84.6 kg and BMI of 29.5 kg/m2.
After 14 weeks of treatment, participants receiving 1.8 mg and 2.4 mg XW003 achieved statistically significant mean body weight loss of 8.32 kg (9.6%) and 7.27 kg (9.0%), respectively, compared to 0.62 kg (0.9%) for those receiving placebo (P<0.0001). At the end of the 14-week treatment, 72.4% of participants in the 1.8 mg XW003 cohort and 66.7% in the 2.4 mg XW003 cohort had lost at least 5% of their body weight, compared to 20% in the placebo group. Weight loss over 10% was achieved in 34.5% and 28.6% of participants receiving 1.8 mg and 2.4 mg XW003, respectively, compared to 10% in the placebo group. XW003 showed statistically significant reductions in participants' waist circumference, hip circumference, and waist-to-hip ratio. Favorable trends were also observed in metabolic parameters, including fasting serum glucose, triglycerides, low-density lipoprotein, and HbA1c.
Summary of Week 14 Interim Results
Placebo (N=10) |
XW003 1.8 mg (N=29) |
XW003 2.4 mg (N=21) |
|
Baseline Demographics (mean) |
|||
Age (years) |
27.5 |
27.7 |
30.0 |
Body Weight (kg) |
83.9 |
88.4 |
79.7 |
BMI (kg/m2) |
28.8 |
30.1 |
29.1 |
Changes from Baseline at Week 14 |
|||
Weight Loss (kg) |
-0.62 kg |
-8.32 kg* |
-7.27 kg* |
Weight Loss (%) |
-0.9 % |
-9.6%* |
-9.0%* |
Weight Loss > 5% |
20 % |
72.4 % |
66.7 % |
Weight Loss > 10% |
10 % |
34.5 % |
28.6 % |
Waist Circumference (cm) |
+0.57 |
-6.39* |
-6.09* |
Hip Circumference (cm) |
+0.93 |
-3.47* |
-3.60* |
Waist/Hip Ratio |
-0.38 |
-3.06* |
-2.97* |
*P<0.0001, versus placebo
Consistent with previous studies, XW003 was generally safe and well tolerated. There were no treatment-related serious adverse events (SAEs) or AEs that were grade 3 or higher. Treatment-related AEs were mild to moderate, with gastrointestinal side effects being the most commonly reported AEs. There were no discontinuations due to AEs related to the study drug.
"Adding to the positive results we released recently from the 20-week Phase 2 clinical trial of XW003 in type 2 diabetes patients in China, we are very pleased to see the strong effects of XW003 in reducing body weight in overweight and obese Chinese volunteers, as well as the confirmation of good safety and tolerability profiles in this Phase 1c/2a study. These results demonstrate significant weight loss and suggest XW003 has a strong potential in the treatment of obesity," said Hai Pan, PhD, founder and CEO of Sciwind. "Besides this Phase 1c/2a trial, XW003 is also being evaluated in a Phase 2 clinical trial in obese patients in Australia and New Zealand with data readouts expected in the coming months. We plan to discuss these results with the Chinese regulatory authorities and, pending the outcome of such discussions, initiate the pivotal clinical trial for obesity in the near future."
About XW003
Glucagon-like peptide-1 (GLP-1) analogs are effective tools in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for NASH. XW003 is a novel, biased long-lasting GLP-1 peptide analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing. XW003 has been shown to be safe and well tolerated in a Phase 1 clinical study. Phase 2 studies are evaluating XW003 as a potential treatment for type 2 diabetes and obesity.
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. Sciwind has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutics delivery platforms and identified several drug candidates based on these core platform technologies. For more information, visit www.sciwindbio.com.