The Amgen logo is displayed outside the Amgen headquarters in Thousand Oaks, California on May 17, 2023.
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Imjan said on Tuesday that its experimental Weight loss injection It helped obese patients lose an average of 20% of their weight in a pivotal one-year mid-stage trial, as the company races to reach the top. The obesity drug market.
The drug, MaryTide, also helped obese and type 2 diabetic patients lose up to 17 percent of their weight after one year. The company said it did not observe a plateau in either group of patients, indicating the potential for further weight loss after 52 weeks.
But the company’s shares fell nearly 5% in premarket trading on Tuesday, as the results appeared to be at the low end of Wall Street expectations. Ahead of the data, several analysts said they expected MaryTide to show at least a 20 percent weight loss in the Phase Two trial, with some expecting as much as 25 percent.
Wall Street is eagerly awaiting the results of the Phase II trial, which shed light on how Amgen’s drug could lead to a blockbuster weight-loss injection. Novo Nordisk And Eli Lilly And a crowded field of treatments is being developed by other drugmakers.
Amgen has just released data from the first part of the two-year trial, which was designed to test different dose sizes, schedules and regimens of Maritide. Jay Bradner, Amgen’s chief scientific officer, said in an earlier interview that the company will use the results of the first phase “to put the finer details” on the design of its late-stage study on the treatment, which is “already deep in planning.” is.” this month.
Amgen has said that MaryTide can offer faster weight loss, potentially better weight maintenance and fewer shots than weekly injections like Novo Nordisk’s Vigovi and Eli Lilly’s Zipbound. That could increase Imjan’s odds of winning a piece of the weight-loss drug market, which some analysts predict. 150 billion dollars a year By the early 2030s.
A late-stage study of Vigovi showed that it led to a 15 percent weight loss over 68 weeks, while Zipbound helped patients lose more than 22 percent of their weight over 72 weeks.
Meritide brings a new approach to weight loss compared to drugs on the market because it is a so-called peptide-antibody conjugate, which refers to a monoclonal antibody linked to two peptides. The peptides activate receptors for a gut hormone called GLP-1, while the antibody blocks receptors for another hormone called GIP hormone.
This is in contrast to Eli Lilly’s obesity drug, Zipbound, which stimulates both GIP and GLP-1. Vigovi activates GLP-1 but does not target GIP, which can also affect how the body breaks down sugar and fat.
Shares of Amgen have risen this year in anticipation of mid-stage trial data. The rally lost steam in recent weeks as one analyst raised questions about MaryTide’s potential. Side effects related to bone density.
Trial design, data
The first part of the phase two trial included 592 patients, including 465 patients with obesity and 127 patients with obesity and type 2 diabetes. The trial tested Maritide in 11 different patient groups, where researchers tested different regimens and dose levels — 140, 280 and 420 milligrams.
For example, some groups used rapid dose escalation, which involves starting patients on a low dose of Meritide and gradually increasing it over four weeks until they reach a higher target dose. Others had smaller dose increases over 12 weeks.
Several groups took Mary Tide once a month, while one group took the highest dose of the drug every other month. Bredner noted that patients with type 2 diabetes “are known to respond less favorably to weight-loss medications,” so Amgen did not place them in a group with higher doses or less frequent doses. Method of taking is used.
Amgen invited patients to participate in the second part of the trial, which examines how sustainable MaryTide’s weight loss is. Bradner said the company is “interested in seeing how quickly people who have lost weight recover after taking the drug.”
The second part of the trial is also looking at any progressive weight loss after the first year on MaryTide and testing the medication even less frequently. Amgen has not said when it will release data from the second part of the trial.
Patients who continued the trial were randomly divided into several groups.
For example, patients who took a 140-milligram dose of MaryTide in the first part of the trial will either continue to take that dose or switch to a placebo for a second year, which would determine if MaryTide’s weight loss How long am I missing? Some people who took 280-milligram doses in the first part of the trial will take lower doses of the drug for a year.
Amgen is also testing the quarterly schedule among some patients who took 420-milligram doses in the first part of the trial. This means patients will get the shot once every 12 weeks.