Amgen's MariTide to Face Phase 3 Trials in Targeting Liver and Kidney Diseases

Amgen is advancing its next-generation obesity drug, MariTide, into a Phase 3 clinical program aimed at addressing obesity in conjunction with other weight-related conditions such as heart, liver, and kidney diseases. The injectable therapy, which activates the GLP-1 receptor while blocking the GIP receptor, demonstrated a 14.5% reduction in body weight during Phase 1 trials.

CEO Robert Bradway announced at the Morgan Stanley Global Healthcare Conference that MariTide could be administered monthly, providing a competitive advantage over weekly treatments like Wegovy, whereas the expanded indication might help secure Medicare coverage, an area that competitors have struggled with for weight-loss-only treatments.

The following article originally appeared in BioSpace.

Amgen is pushing its next-generation obesity therapy MariTide into a broad late-stage development program to assess the candidate’s potential in other weight-related conditions, such as heart, kidney and liver diseases.

Speaking at the Morgan Stanley Global Healthcare Conference on Wednesday, Amgen CEO Robert Bradway told investors that the pharma is “rapidly” advancing MariTide through Phase II, after which it will initiate “a robust, wide-ranging Phase III clinical program” for the candidate.

“We look forward to generating data that will show what we can achieve in patients that are obese or living with overweight and what we can do in that context for patients that are at high risk of heart disease, renal disease, liver disease,” Bradway said.

Having an obesity treatment that can also target other conditions “represents an exciting opportunity” for the company and its shareholders, he noted.

MariTide is an injectable bispecific molecule that works by simultaneously activating the GLP-1 receptor while also blocking the GIP receptor. Through this mechanism of action, MariTide is thought to promote the release of insulin from the pancreas, suppress appetite and improve various other metabolic parameters. The candidate is currently in Phase II development.

In February 2024, Amgen released Phase I data touting a 14.5% body weight reduction after 85 days. By comparison, placebo counterparts gained 1.5% body weight at this same time point. With these promising data, Amgen announced in its first-quarter 2024 business report in May that it would be throwing its weight behind MariTide, with plans to accelerate development through Phase III.

At the time, CSO James Bradner reiterated Amgen’s confidence in MariTide, noting that the candidate can potentially “address important unmet medical needs” in obesity, diabetes and related conditions.

A potential advantage that MariTide has over its well-established competitors—Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound—is a longer duration of effect. During Wednesday’s Morgan Stanley conference, Bradway pointed to MariTIde’s “antibody backbone” as a key feature that sets it apart from the currently commercially available obesity treatments and provides its longer treatment duration.

“Our medicine is likely to be administered monthly or less frequently than that,” Bradway said, whereas Wegovy and Zepbound are injected weekly.

Aiming for a broader indication could also help Amgen overcome a crucial barrier that Novo and Lilly faced with their incretin therapies when they initially hit the market—coverage. Medicare does not cover these drugs when used for weight loss but might do so when they are prescribed for other conditions.

In March, Medicare announced that it will cover Wegovy when used to reduce the risk of heart attack, stroke and other cardiovascular conditions in overweight or obese adults. Meanwhile, Lilly is working to expand Zepbound’s label into obstructive sleep apnea in an effort to secure similar Medicare coverage.

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