Amgen Launches Phase I Clinical Trial of Monthly Subcutaneous Obesity Drug AMG 133 in China

Feb 24, 2024 07:21 CST Updated 07:21

Amgen

Developer of Treatment Drugs for Serious Diseases

Recently,According toCDE Clinical Trial RegistrationCompared with the information disclosure platform,AmgenAdvanceAMG 133In ChinaLaunchI Phase Clinical Trial (Registration Number:CTR20240555），Aimed to evaluateIn Chinese obese or overweight subjects,Single timePharmacokinetics, Safety, and Tolerability of AMG 133 After Subcutaneous (SC) Administration.

Source: CDE Official Website

AmgenAMG 133 It is an antibody fusion protein that inhibits GIPR through a GIPR inhibitory antibody fused with GLP-1, activating GLP-1R while inhibiting GIPR. This mechanism differs from Eli Lilly's GIPR/GLP-1R dual agonist, tirzepatide.

According to the Insight database, AMG 133 was first initiated in clinical trials in the United States in July 2020 for obese patients. In China, it was first reported for clinical trials in September last year, approved for clinical trials in November of the same year, and recently registered to initiate clinical trials.

Previously announced Phase I clinical data by Amgen showed,After 12 weeks of treatment, subjects in the high-dose AMG 133 group experienced weight loss of up to 14.5%.; Although it is only small-sample Phase 1 clinical data, it still shows the therapeutic potential of AMG 133 to a certain extent. Moreover, compared with once-weekly dosing, the advantage of once-monthly dosing is also quite significant.

Source: Amgen Official Website Materials

Currently, Amgen has initiated a Phase II clinical trial.(Registration Number:NCT05669599）For obese or overweight patients with or without type 2 diabetes, the recruitment of all subjects was completed in November last year, and the primary endpoint is expected to be reached in October this year.

In China, GMA106 from Hongyun Huaning has a mechanism similar to AMG133.

In June last year, China Biologic ProductsUp to $57 millionThe upfront payment and milestone payments, etc., introduced GMA106 from Gmax Biopharm, obtaining exclusive development and commercialization rights in Greater China, officially entering the billion-dollar weight loss market.

GMA106 has a long molecular half-life, which is expected to allow for treatment at a frequency of once every 2 weeks or once every 4 weeks, improving long-term medication adherence; GMA106 entered Phase I clinical trials in Australia in November 2021. Preliminary efficacy data, without unblinding, shows that GMA106 has the potential to prevent weight regain for 3-5 months after discontinuation of dosing.

In China, an Ib/II phase clinical trial application was submitted to the CDE in October last year and has been accepted. GMA106 plans to further confirm the safety and tolerability of multiple doses of 80 mg, 120 mg, and 160 mg in overweight and obese populations through an Ib phase study. The II phase study will explore the preliminary efficacy of different doses and dosing frequencies after 24 weeks and 36 weeks of treatment in different cohorts.

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