Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Phase 2 studies are evaluating XW003 as a potential treatment for type 2 diabetes and obesity. XW003 has been shown to be safe and well tolerated in a Phase 1 clinical study. XW003 is a novel, biased long-lasting GLP-1 peptide analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing. 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.
INKLET 2 TRIAL TRIAL
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." "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. 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. "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. There were no discontinuations due to AEs related to the study drug. Treatment-related AEs were mild to moderate, with gastrointestinal side effects being the most commonly reported AEs.
There were no treatment-related serious adverse events (SAEs) or AEs that were grade 3 or higher. At baseline, participants had a mean body weight of 84.6 kg and BMI of 29.5 kg/m 2.Ĭonsistent with previous studies, XW003 was generally safe and well tolerated. 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. 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. The interim analysis was conducted after all participants completed the core treatment phase (Part A).Įligible participants included healthy, non-diabetic subjects with a body mass index (BMI) between 24.0 and 35.0 kg/m 2. 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 Phase 1c/2a trial, which is being conducted in China, includes non-diabetic overweight or obese adult subjects.
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. 8, 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 was safe and well tolerated with gastrointestinal side effects as the most commonly reported adverse events Up to 72.4% of participants achieved weight loss of at least 5% at week 14 Mean body weight loss of 9.6% and 9.0% in participants receiving 1.8 mg and 2.4 mg XW003 for 14 weeks, respectively
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