Amgen Plans Phase III Trial for New Obesity Drug Targeting Liver and Kidney Diseases

Amgen's upcoming obesity therapy, MariTide, is advancing into an extensive late-stage development phase to evaluate its potential in treating weight-related conditions such as heart, kidney, and liver diseases, as revealed by CEO Robert Bradway at the Morgan Stanley Global Healthcare Conference.

Bradway informed investors that MariTide is progressing rapidly through Phase II, with plans to embark on an extensive Phase III clinical program following successful results. The goal is to generate data demonstrating MariTide's efficacy in obese or overweight patients and its potential benefits for those at high risk of heart, renal, and liver diseases.

MariTide, an injectable bispecific molecule, operates by activating the GLP-1 receptor while also blocking the GIP receptor. This dual mechanism promotes insulin release from the pancreas, suppresses appetite, and improves various metabolic parameters. Currently in Phase II, the molecule has shown promising results. In February 2024, Amgen reported Phase I data indicating a 14.5% reduction in body weight after 85 days, contrasting with a 1.5% weight gain in the placebo group. Encouraged by these findings, Amgen declared in its first-quarter 2024 business report that it plans to accelerate MariTide's development through Phase III.

James Bradner, Amgen's Chief Scientific Officer, highlighted the potential of MariTide to address significant unmet medical needs in obesity, diabetes, and related conditions. One of MariTide's key advantages over competitors like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound is its longer duration of effect. At the Morgan Stanley conference, Bradway emphasized MariTide’s "antibody backbone" as a feature that sets it apart from existing obesity treatments and contributes to its extended treatment duration.

Amgen aims to position MariTide as a monthly or less frequently administered treatment, in contrast to the weekly injections required for Wegovy and Zepbound. This distinction could provide a competitive edge in the market and improve patient adherence to the treatment regimen.

A broader indication for MariTide could also help Amgen navigate a significant challenge faced by Novo and Lilly with their incretin therapies—insurance coverage. Medicare does not cover these drugs when prescribed solely for weight loss but may do so for other conditions. In March, Medicare announced coverage for Wegovy for reducing the risk of heart attack, stroke, and other cardiovascular conditions in overweight or obese adults. Similarly, Lilly is seeking to expand Zepbound’s label to include obstructive sleep apnea, aiming for comparable Medicare coverage.

Amgen's strategy involves leveraging the broader therapeutic potential of MariTide to secure Medicare coverage, which could be a crucial factor in the therapy's commercial success. By demonstrating efficacy in treating multiple weight-related conditions, Amgen hopes to meet the needs of patients and achieve a favorable position in the competitive obesity treatment market.

In summary, Amgen is advancing MariTide through an extensive clinical program to explore its potential in treating various weight-related conditions. With promising early data and a strategy to secure broader indications and insurance coverage, Amgen is positioning MariTide as a potential leader in the next generation of obesity therapies.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!