Robust HbA1c reduction of 2.4% was observed with 1.2 mg XW003 dose - Up to 88% of participants achieved HbA1c ? 7% and up to 72% achieved HbA1c ? 6.5% at the end of the 20-week treatment - XW003 was safe and well tolerated with gastrointestinal side effects as the most commonly reported adverse events Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, today announced positive results from a 20-week Phase 2 clinical trial of XW003 (Ecnoglutide) in Chinese adults with type 2 diabetes (T2D). The results demonstrated that weekly subcutaneous administration of XW003 for up to 20 weeks was safe and well tolerated and achieved robust reductions in HbA1c, meeting the study's primary endpoints. The Phase 2 study is a multi-center, randomized, placebo-controlled clinical trial conducted in China with the participation of over 20 hospital-based certified study centers. A total of 145 adult patients with T2D, whose disease was inadequately controlled through lifestyle management or oral anti-diabetic therapy prior to entering the study, were randomized into four cohorts to receive once-weekly subcutaneous injections of 0.4 mg, 0.8 mg, or 1.2 mg XW003 or placebo for 20 weeks. At baseline, participants had a mean HbA1c of 8.55%. At week 20, participants receiving 0.4 mg, 0.8 mg, and 1.2 mg XW003 had statistically significant HbA1c reductions from baseline of 1.8%, 1.9% and 2.4%, respectively, compared to 0.5% in participants receiving placebo (P < 0.0001). At the end of the treatment, 88% of participants in the 1.2 mg XW003 cohort achieved HbA1c ? 7.0%, the target recommended by the American Diabetes Association for people with diabetes, compared to 21% in the placebo group. HbA1c ? 6.5% was achieved for 72% of participants in the 1.2 mg XW003 cohort, compared to 9% in the placebo group. Despite the participants' relatively low mean body weight at baseline, XW003 significantly reduced participants' body weight in a dose-dependent fashion. XW003 also led to improvements in additional cardiometabolic parameters, including fasting and post-meal serum glucose, waist circumference, blood pressure, and liver transaminases, showing the potential to provide patients with an overall treatment benefit. XW003 was generally safe and well tolerated with a similar incidence of adverse events (AEs) across treatment groups. There were no treatment-related serious adverse events (SAEs) or occurrence of serious hypoglycemia. Treatment-related AEs were all mild to moderate, with gastrointestinal side effects, such as diarrhea, nausea, constipation, and loss of appetite, being the most commonly reported AEs. The discontinuation rate due to AEs was less than 1% in participants receiving XW003. "Type 2 diabetes is a debilitating disease with the incidence rate steadily growing in China. It is often accompanied with cardiometabolic comorbidities such as obesity, high blood pressure, dyslipidemia, and fatty liver disease, seriously impacting patients' lives. More efficacious and better tolerated therapies are still urgently needed to address this great need," said Dalong Zhu, MD, Professor of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School and Principal Investigator of the study. "I am very pleased to see the highly positive results from this Phase 2 clinical trial, particularly the strong effect of XW003 in reducing HbA1c indicating a best-in-class potential among this class of drugs. We look forward to continuing this collaborative effort with the clinical investigators, patients, and Sciwind team to further develop this promising drug candidate to help patients in need of new therapies." "We are very excited to receive the positive topline results from this Phase 2 trial, which reenforce that XW003 has strong potential to address significant unmet needs for patients with T2D and other metabolic conditions," said Hai Pan, PhD, founder and CEO of Sciwind. "We plan to discuss these results with the Chinese regulatory authorities soon and prepare to initiate, pending the outcome of such discussions, the pivotal Phase 3 clinical trial in China in the near future." XW003 is also currently being investigated in clinical trials for obesity in China and Australia. Data readouts from these studies are expected later in the year. 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.
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