Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, announced today the initiation 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.

The Phase 1 trial is a double-blind, randomized, placebo controlled, single and multiple ascending dose study that is being conducted in the US. The study plans to enroll up to 104 healthy volunteers and patients with type 2 diabetes. Participants in the multiple ascending dose cohorts of the trial, which will include healthy individuals with elevated body mass index and patients with type 2 diabetes, will be treated with study drug for 6 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. 

"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 Martijn Fenaux, PhD, 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 topline data from this trial in the second half of 2023."