Sciwind Biosciences Announces Positive Results from Phase 1 Clinical Trial of XW004, an Oral Formulation of Long-acting GLP-1 Analog Ecnoglutide

Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic diseases, today announced positive interim results from the first four cohorts of a Phase 1 clinical trial of oral ecnoglutide (XW004). Ecnoglutide is a long-acting, cAMP signaling biased, glucagon-like peptide-1 (GLP-1) analog that is being developed for the treatment of type 2 diabetes and obesity. XW004 is an oral tablet formulation of ecnoglutide.The Phase 1 trial (NCT05184322) is a randomized, double-blind, placebo-controlled multiple ascending dose study that enrolled 42 healthy (Cohorts 1-3) and 14 healthy obese (Cohort 4) participants in Australia. Participants were randomized to receive placebo or XW004 as once-daily oral tablets. In Cohorts 1-3, target doses were 7 mg, 15 mg, or 30 mg XW004 once-daily for 2 weeks; in Cohort 4 the target dose was 30 mg XW004 once-daily for 6 weeks. Treatment periods included gradual dose escalation to the target doses. Safety, tolerability, pharmacokinetics and changes in mean body weight from baseline were evaluated.Overall safety and tolerability of oral ecnoglutide were consistent with the established profile of GLP-1 peptide agonists. The most frequently reported adverse events included nausea, headache, diarrhea, vomiting, and decreased appetite. The majority of adverse events were mild to moderate in severity and occurred mostly during the dose-escalation periods.At baseline, participants had a mean body weight of 75.6 to 77.9 kilograms for Cohorts 1-3 and 100.1 kilograms for Cohort 4. Mean BMI at baseline was 25.8 to 26.1 kg/m² for Cohorts 1-3 and 32.9 kg/m² for Cohort 4. In Cohorts 1-3, treatment with doses up to 7, 15, or 30 mg XW004 once-daily for 2 weeks resulted in body weight changes of -3.6%, -3.4%, and -6.6%, respectively, compared to -0.9% for the placebo group. In obese participants (Cohort 4), treatment with doses up to 30 mg XW004 once-daily for 6 weeks resulted in -6.8% body weight loss at end of treatment, compared to -0.9% for the placebo group. In addition, pharmacokinetics of XW004 showed good absorption after oral administration.

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