Sciwind Biosciences has initiated of dosing in a Phase 1 clinical trial evaluating XW014, a novel oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist. XW014 is being developed for the treatment of obesity and type 2 diabetes mellitus (T2DM).
The Phase 1 trial is a double-blind, randomised, placebo controlled, single and multiple ascending dose study that is being conducted in the US. The study plans to enrol up to 104 healthy volunteers and patients with T2DM. Participants in the multiple ascending dose cohorts of the trial, which will include healthy individuals with elevated body mass index and patients with T2DM, will be treated with study drug for six weeks. The objective of the study is to evaluate the safety and tolerability, food effect, pharmacokinetics, pharmacodynamics, as well as early treatment effects of XW014.
XW014 is an orally bioavailable small molecule GLP-1 receptor agonist in development for the treatment of obesity and type 2 diabetes. As a small molecule, XW014 is easier to manufacture than GLP-1 peptide drugs and readily bioavailable after oral dosing. It has the potential to be co-formulated with other oral drugs of complementary mechanisms to generate more effective combination treatments for metabolic diseases. GLP-1 is an incretin peptide hormone that is naturally released after a meal and acts on the digestive tract, liver, pancreas, and central nervous system to maintain physiological health. GLP-1 receptor agonists have shown clinical benefits in treating obesity, T2DM and liver disease.
"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," said Dr Martijn Fenaux, SVP of Nonclinical Development & Translational Science at Sciwind. "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 1 study is an important first step for the development of this promising molecule. We expect to report initial top-line data from this trial in the second half of 2023."