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Hangzhou Xianweida Biotechnology Co.
, Ltd.
, a clinical-stage biotechnology company focusing on the research and development of innovative treatments for chronic metabolic diseases, announced today that it has completed the administration of the first subject in the Phase I clinical trial of XW004
.
XW004 is an oral formulation of Ecnoglutide, a novel, long-acting GLP-1 polypeptide drug independently developed by Xianweida for the treatment of obesity, type 2 diabetes and NASH
.
In combination with oral absorption enhancers, Econoglutide prevents degradation in the gastrointestinal tract and facilitates its entry into the bloodstream, allowing for once-daily oral dosing
.
Preclinical studies have shown that XW004 has good safety and efficacy
.
This single-center, double-blind, placebo-controlled and multiple ascending dose (MAD) study will evaluate XW004 in approximately 56 healthy volunteers at doses up to 30 mg daily
.
In this clinical study conducted in Australia, subjects will receive study drug once daily for 15 days followed by a 21-day treatment-free follow-up period
.
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW004
.
"As a once-daily oral GLP-1 tablet, XW004 is expected to provide a more convenient treatment option for patients with metabolic diseases and improve overall compliance in a broader patient population
.
It is also suitable for developing oral combination therapy with other drugs, In order to further improve the therapeutic effect
.
" Dr.
Pan Hai, founder and CEO of Xianweida, said, "The initiation of this Phase 1 MAD clinical study is the first step in developing XW004 as a safe and effective therapy for patients with metabolic diseases
.
"