Wednesday, January 24, 2024
Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on developing innovative therapies for metabolic diseases, has reported positive interim results from the initial four cohorts of a Phase 1 clinical trial for oral ecnoglutide (XW004). Ecnoglutide is a long-acting, cAMP signaling biased, glucagon-like peptide-1 (GLP-1) analog designed for the treatment of type 2 diabetes and obesity. XW004 is the oral tablet formulation of ecnoglutide.
The Phase 1 trial (NCT05184322) was a randomized, double-blind, placebo-controlled multiple ascending dose study conducted in Australia, with 42 healthy participants (Cohorts 1-3) and 14 healthy obese participants (Cohort 4). Participants were given either placebo or XW004 as once-daily oral tablets. Target doses for Cohorts 1-3 were 7 mg, 15 mg, or 30 mg XW004 once-daily for 2 weeks, and for Cohort 4, the target dose was 30 mg XW004 once-daily for 6 weeks. The study assessed safety, tolerability, pharmacokinetics, and changes in mean body weight from baseline.
The safety and tolerability of oral ecnoglutide were consistent with the established profile of GLP-1 peptide agonists. Common adverse events included mild to moderate nausea, headache, diarrhea, vomiting, and decreased appetite, predominantly occurring during dose-escalation periods.
Sciwind Biosciences, expressed optimism, stating, "We are very encouraged by the favorable safety, efficacy, and pharmacokinetic profile of XW004 observed in this study. The strong body weight loss results after short-term administration support the development of oral ecnoglutide for the treatment of obesity and type 2 diabetes."
Building on the results of Cohorts 1-4, the study will continue to assess additional dosing regimens, including once-weekly oral administration of XW004 in participants with obesity. Mohammed Junaidi, MD, Sciwind Vice President of Clinical Development, highlighted the potential benefits of less frequent dosing regimens, aiming to enhance patient compliance, address manufacturing challenges, and broaden access to this drug class for diverse patient populations. He added, "If successfully developed, XW004 has the potential to become the first once-weekly oral GLP-1 receptor agonist for the treatment of metabolic conditions."
Ecnoglutide (XW003 and XW004) is part of the GLP-1 analog class, known for its effectiveness in managing type 2 diabetes, obesity, and clinical potential for treating NASH. XW003, a cAMP signaling biased, long-acting GLP-1 analogue, has demonstrated treatment benefits for patients with type 2 diabetes and obesity while being safe and well-tolerated in clinical studies. XW004, on the other hand, represents an oral tablet formulation of ecnoglutide.
Source: prnewswire.com
