- Mean body weight loss of 11.1% in participants receiving once-weekly injections of 2.4 mg XW003 for 18 weeks
- 88.5% and 57.7% of participants receiving 2.4 mg XW003 for 18 weeks achieved weight loss of ≥5% and ≥10%, respectively
- XW003 was safe and well tolerated, with an adverse event profile consistent with other GLP-1 analogs
SAN FRANCISCO and HANGZHOU, China, Oct. 28, 2022 /PRNewswire/ -- Sciwind Biosciences, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, announced today positive results from an interim analysis of the on-going Phase 2b clinical trial of XW003 (ecnoglutide) in patients with obesity. XW003 is a novel, long-lasting glucagon-like peptide-1 (GLP-1) analog being developed for the treatment of type 2 diabetes and obesity.
XW003 is currently being studied in a multi-center, open-label, active-controlled Phase 2b clinical trial in participants with a body mass index (BMI) ≥30 kg/m2. The trial is being conducted at nine sites in Australia and New Zealand, with 206 participants enrolled. Participants were randomized to receive target doses of XW003 at 1.2, 1.8, or 2.4 mg as once weekly injections or liraglutide (Saxenda®) at 3.0 mg as once daily injections for 26 weeks. Doses were increased by titration for up to 14 weeks before reaching the target dose. The interim analysis was conducted when approximately 140 participants had completed 18 weeks of treatment. At baseline, participants had a mean body weight of 99.6 kg and BMI of 34.9 kg/m2.
After 18 weeks of treatment, participants receiving 2.4 mg XW003 weekly achieved a mean body weight reduction from baseline of 11.1% (10.9 kg), compared to 7.9% (8.1 kg) for participants receiving 3.0 mg liraglutide daily injections (P=0.009). After 18 weeks of treatment, the proportion of participants achieving ≥5% body weight loss from baseline was 88.5% for 2.4 mg XW003 and 70.4% for liraglutide, while those reaching ≥10% body weight loss from baseline was 57.7% for 2.4 mg XW003 and 33.3% for liraglutide. It was further noted that the weight loss trend among participants receiving liraglutide started to plateau after approximately 10 weeks of dosing whereas participants receiving XW003 maintained progressive, steady weight loss throughout the interim analysis period and the trend continued beyond week 18. Favorable trends were also seen for other efficacy parameters, including waist circumference, BMI, and blood glucose.
Overall, treatment with XW003 was safe and well tolerated, with an adverse event (AE) profile consistent with other GLP-1 drugs. After 18 weeks of dosing, the proportions of participants reporting any AE during the treatment period were similar among the four treatment groups. The most frequently reported AEs were gastrointestinal, including nausea, diarrhea, constipation, and vomiting. Most gastrointestinal events were mild to moderate in severity, transient, and occurred during the dose-escalation period.
"Consistent with the results we announced previously, the positive interim results from this on-going Phase 2b clinical study in obese participants reaffirmed the strong efficacy and safety profile of XW003 in treating patients with obesity and other metabolic diseases," said Dr. Mohammed Junaidi, Vice President of Clinical Research at Sciwind. "We are particularly excited to see the weight loss trend in participants receiving XW003 continuing beyond 18 weeks of dosing, suggesting that further weight reductions are possible with prolonged treatment."
"With these promising results, we are very enthusiastic about progressing XW003 to Phase 3 pivotal trials in China for the treatment of obesity and type 2 diabetes, as well as exploring a broader global development strategy for XW003," said Dr. Hai Pan, founder and CEO of Sciwind Biosciences. "We will discuss these results, along with results from other studies of XW003, with the Chinese regulatory authorities soon and, pending the outcome of such discussions, initiate pivotal clinical trials in the near future."
The current Phase 2b obesity study is expected to complete by the end of 2022, with full results anticipated to be available in the first half of 2023.
About XW003 (Ecnoglutide)
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 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-lasting GLP-1 peptide analog XW003 (ecnoglutide) (Phase 2), 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.