XW014 is a small molecule glucagon-like peptide-1 (GLP-1) receptor agonist.
Being conducted in the US, the double-blind, placebo-controlled, randomised, single and multiple ascending dose clinical trial plans to recruit up to 104 healthy volunteers and subjects with type 2 diabetes.
The trial’s multiple ascending dose cohorts will include healthy individuals who have an elevated body mass index, and patients with type 2 diabetes.
These participants will receive the study drug for a period of six weeks.
The study is aimed at assessing XW014’s tolerability and safety, food effect, pharmacokinetics, and pharmacodynamics.
It will also evaluate the early treatment effects of the drug.
Sciwind Biosciences Nonclinical Development & Translational Science senior vice-president Martijn Fenaux said: “As an orally bioavailable small molecule GLP-1 receptor agonist, XW014 has the potential to become a new and differentiated treatment option for patients with obesity and type 2 diabetes, without the burden of daily or weekly injections.
“XW014 is also amenable to the development of fixed-dose oral combination therapies with other classes of drugs of complementary mechanisms to further improve treatment outcomes.
“Initiation of this Phase I study is an important first step for the development of this promising molecule.”
Initial topline data from the trial is expected in the second half of next year.
XW014 is readily bioavailable following oral dosing, and can be co-formulated with other oral drugs of complementary mechanisms for generating combination treatments to treat metabolic diseases.
In April this year, Sciwind initiated dosing of the subjects in a Phase I clinical trial of XW004 in Australia.