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Sciwind’s ecnoglutide oral GLP-1 analogue reveal positive results

Sciwind Biosciences has 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 signalling biased, glucagon-like peptide-1 (GLP-1) analogue 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 randomised, 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 randomised to receive placebo or XW004 as once-daily oral tablets. In Cohorts 1-3, target doses were 7mg, 15mg or 30mg XW004 once-daily for two weeks; in Cohort 4 the target dose was 30mg XW004 once-daily for six 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, diarrhoea, 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 26.1kg/m² for Cohorts 1-3 and 32.9kg/m² for Cohort 4. In Cohorts 1-3, treatment with doses up to 7, 15 or 30 mg XW004 once-daily for two weeks resulted in body weight changes of -3.6%, -3.4% and -6.6%, respectively, compared to -0.9% for the placebo group (Table). In obese participants (Cohort 4), treatment with doses up to 30mg XW004 once-daily for six 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.

"We are very encouraged by the favourable safety, efficacy, and pharmacokinetic profile of XW004 observed in this study. The strong body weight loss results after short-term administration support the development of oral ecnoglutide for the treatment of obesity and type 2 diabetes" said Hai Pan, founder and CEO of Sciwind Biosciences.

Based on the results of Cohorts 1-4, the study is continuing and will evaluate additional dosing regimens, including once-weekly oral administration of XW004 in participants with obesity.

"We believe that less frequent dosing regimens can significantly improve patient compliance, overcome manufacturing challenges, and greatly increase access to this drug class for broad patient populations," said Dr Mohammed Junaidi, Sciwind Vice President of Clinical Development. "If successfully developed, XW004 has the potential to become the first once-weekly oral GLP-1 receptor agonist for the treatment of metabolic conditions."


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