Sciwind Biosciences has commenced dosing of the subjects in Phase I clinical trial of the oral tablet formulation of Ecnoglutide, XW004, in Australia.
Ecnoglutide is a new long-lasting glucagon-like peptide-1 (GLP-1) peptide analogue being developed to treat obesity, type 2 diabetes and non-alcoholic steatohepatitis (NASH).
The peptide agonist is co-formulated with an oral absorption booster to avert deactivation in the digestive tract and also permits daily oral dosing.
The double-blind, single-centre, placebo-controlled and multiple ascending dose (MAD) trial will assess XW004 at doses of up to 30mg administered daily in nearly 56 healthy subjects.
Trial subjects will receive the oral drug once a day for 15 days followed by a treatment-free period of 21 days.
Analysing the safety, tolerability, pharmacokinetics and pharmacodynamics of XW004 is the objective of the trial.
Sciwind Biosciences founder and CEO Dr Hai Pan said: “As a once-daily oral GLP-1 tablet, XW004 has the potential to offer a more convenient treatment option for patients with metabolic disease and improve the overall compliance in broader patient populations.
“It is also amenable to developing oral combination treatments with other drugs to further enhance treatment outcomes.
“Initiation of this Phase I MAD study is an important first step towards developing XW004 as a safe and effective treatment for patients living with metabolic disease.”
According to data from preclinical studies, XW004 was found to have a good safety profile.
A clinical-stage biopharmaceutical company, Sciwind focuses on the discovery and development of novel therapies to treat metabolic diseases.
This January, the company began dosing subjects in a Phase IIb clinical trial of XW003 in individuals with obesity.
A long-lasting GLP-1 analogue, XW003 was reported to be safe and well-tolerated and elicited dose-based weight reductions in prior trials.