PegBio Completes First-in-Human Single-Dose Trial of CR059 With Four-Week Observations Obtained

Reuters
Mar 06
PegBio Completes First-in-Human Single-Dose Trial of CR059 With Four-Week Observations Obtained

PegBio Co., Ltd. said its next-generation GLP-1 receptor agonist candidate CR059, developed using circular RNA protein replacement technology and delivered via a lipid nanoparticle system, has completed single-dose administration in a first-in-human trial in subjects with type 2 diabetes and has obtained four-week clinical observations. The company reported that four weeks after a single dose, glycated hemoglobin (HbA1c) and fasting blood glucose continued to improve versus baseline, continuous glucose monitoring showed time in range (4–10 mmol/L) increased, and mean blood glucose decreased. In preclinical studies, PegBio reported that in db/db mice CR059 showed a clear dose-response and superior metabolic intervention effects versus semaglutide under head-to-head conditions. In a spontaneous type 2 diabetes rhesus monkey model, once-monthly subcutaneous dosing (D1 and D32) significantly reduced fasting plasma glucose with effects persisting across the dosing interval, and HbA1c continued improving versus baseline until D88. In healthy rhesus monkeys, a single subcutaneous dose was reported to maintain metabolic effects for several weeks, with approximately 11.8% weight loss at five weeks after one administration.

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