Tides Express | Anjin AMG133 Approved for Clinical Use in China
Editor of the Peptide Biochemistry Content Team
On November 20, 2023, the CDE official website announced that Amgen’s Class 1 new drug AMG 133 has obtained implied clinical trial approval in China and is intended to be developed for weight control. AMG 133 is a potential “first in class” antibody peptide conjugate drug under development, administered once a month. It can activate glucagon like peptide-1 receptor (GLP-1 R) and inhibit gastric inhibitory peptide receptor (GIPR) to exert its effect. In the Phase 1 clinical study previously announced by Anjin, participants experienced a 14.5% weight loss after being treated with the highest dose of AMG 133 for 3 months (12 weeks).
AMG133 is a first in class bispecific antibody peptide conjugate that is indicated for obesity and only requires subcutaneous injection once every 4 weeks. This drug not only inhibits glucose dependent insulinotropic polypeptide receptor (GIPR), also known as gastric inhibitory polypeptide receptor, but also activates glucagon like peptide-1 receptor (GLP-1 R). GLP-1 and GIP are two natural enteropancreatic hormones that have been shown to reduce food intake, regulate metabolism, aid in weight loss, and lower blood sugar levels.
This investigational therapy can activate GLP-1 receptors while inhibiting the activity of GIPR, thereby regulating multiple signaling pathways associated with obesity and metabolic disorders. Among them, activating GLP-1R can delay gastric emptying and suppress appetite, thereby achieving the effect of weight loss. In addition, many genetic epidemiological studies have shown that the decrease in body mass index (BMI) in people of different ethnic backgrounds is associated with low expression of GIPR.
In December 2022, Amgen released the latest phase I clinical trial data of AMG 133, which aims to evaluate the safety, tolerance, pharmacokinetics and pharmacodynamics of AMG 133 in obese and non diabetes population. Participants were randomly assigned to receive subcutaneous injection of AMG 133 or placebo treatment, and the trial was divided into two cohorts: single dose escalation (SAD) or multiple dose escalation (MAD). The results of the MAD cohort study showed that on day 85 (approximately 3 months), compared to baseline, the two groups of subjects who received low doses (140mg, administered every four weeks) and high doses (420mg, administered every four weeks) had an average weight loss of 7.2% and 14.5%, respectively. AMG133 has good safety and no significant safety issues were found in the study. Most adverse reactions are mild and transient, and are related to the gastrointestinal tract, with nausea and vomiting being the most common. Most events resolve within 48 hours.
Anjin Company is committed to unleashing the potential of biology to benefit patients with serious illnesses worldwide. In order to achieve this vision, Anjin has long focused on the exploration, research and development, production, and sales of innovative drugs for humans, and strives to reveal the complexity of diseases and gain insights into the basic mechanisms of human biology through the use of cutting-edge tools such as human genetics.
Anjin focuses on the field of diseases with huge medical needs that are far from being met, utilizing its advanced experience in biopharmaceuticals to make outstanding contributions to improving human health and quality of life. Since its establishment in 1980, Anjin has become one of the world’s leading independent biotechnology companies, providing innovative drugs to millions of patients worldwide, while also possessing a group of highly promising drugs under development.
