Obese participants, who were administered with up to 30mg oral ecnoglutide once-daily for six weeks, achieved a mean body weight reduction of 6.8% from baseline compared to a 0.9% reduction for the placebo
Sciwind Biosciences reports positive data from Phase 1 trial of oral ecnoglutide. (Credit: James Yarema on Unsplash)
Sciwind Biosciences said that oral ecnoglutide (XW004) has achieved a positive mean body weight reduction in the first four cohorts of a Phase 1 clinical trial as per interim results.
XW004 is an oral tablet formulation of ecnoglutide, a long-acting, cAMP signalling biased, glucagon-like peptide-1 (GLP-1) analog. It is being developed to treat type 2 diabetes and obesity.
The Phase 1 study assessed its safety, tolerability, pharmacokinetics, and changes in mean body weight from baseline.
The randomised, double-blind, placebo-controlled multiple ascending dose study recruited 42 healthy adults in cohorts 1-3 and 14 healthy obese participants in cohort 4 in Australia.
In the trial, the participants were randomised to receive a placebo or XW004 as once-daily oral tablets. The treatment periods consist of gradual dose escalation to the target doses.
According to the results, the participants’ mean body weight at baseline was 75.6kg to 77.9kg for cohorts 1-3 and 100.1kg for cohort 4.
For the first three cohorts, the mean body mass index (BMI) was 25.8 kg/m² to 26.1kg/m², and for cohort 4, it was 32.9kg/m².
In addition, body weight decreases of 3.6%, 3.4%, and 6.6% were seen in Cohorts 1-3 respectively after treatment with doses up to 7mg, 15mg, or 30mg XW004 once-daily for two weeks, as opposed to a 0.9% reduction for the placebo group.
Treatment with doses up to 30mg XW004 once-daily for six weeks led to -6.8% body weight loss at the end of treatment in obese participants, compared to -0.9% for the placebo group.
Furthermore, XW004’s pharmacokinetics demonstrated good absorption following oral dosing.
Oral ecnoglutide’s overall safety and tolerability were consistent with the known characteristics of GLP-1 peptide agonists.
Sciwind Biosciences founder and CEO Hai Pan said: “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.”
Based on the outcomes of cohorts 1-4, the trial is ongoing and will assess alternative dose regimens including once-weekly oral administration of XW004 in obese people.