Amgen Receives Chinese IND Approval for Monthly Obesity Therapy AMG 133

Intelligent Finance APP learned on November 20 that the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration announced that Amgen's (AMGN.US) submitted new drug AMG 133 of Class 1 has obtained tacit approval for clinical trials in China, intended for development in weight management. Public information shows that AMG 133 is a potential "first-in-class" antibody-peptide conjugate under research, administered once a month. It activates glucagon-like peptide-1 receptor (GLP-1R) and inhibits gastric inhibitory polypeptide receptor (GIPR) to exert its effects. In an earlier published Phase 1 clinical study by Amgen, subjects treated with the highest dose of AMG 133 for three months (12 weeks) experienced a 14.5% reduction in body weight.

Reportedly, in December 2022, Amgen announced the latest Phase 1 clinical trial data for AMG 133. The study aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMG 133 in obese individuals without diabetes. Participants were randomly assigned to receive either subcutaneous injections of AMG 133 or a placebo. The trial was divided into two cohorts: single ascending dose (SAD) and multiple ascending dose (MAD). Results from the MAD cohort showed that by Day 85 (approximately three months), compared to baseline, participants receiving low-dose (140mg, administered once every four weeks) and high-dose (420mg, administered once every four weeks) treatments experienced average weight reductions of 7.2% and 14.5%, respectively. Notably, the weight loss effects were largely maintained even after discontinuation of the treatment. The most common treatment-emergent adverse events (TEAEs) were temporary and mild, with most resolving within 48 hours.

According to the ClinicalTrials website, Amgen has initiated a Phase 2 clinical study aimed at comparing and evaluating the efficacy, safety, and tolerability of three selected doses of AMG 133 in inducing and maintaining weight loss over 52 weeks in patients who are overweight or obese without diabetes and in those who are overweight or obese with type 2 diabetes, compared to placebo.