The Amgen logo is displayed outside of Amgen headquarters in Thousand Oaks, California, on May 17, 2023.
Mario Tama | fake images
amgen on Tuesday said its experimental weight-loss shot helped obese patients lose up to 20% of their weight on average after a year in a critical mid-stage trial, as the company races to join the burgeoning market. of obesity medications.
The drug MariTide also helped patients with obesity and type 2 diabetes lose up to 17% of their weight after one year. The company said it did not see a plateau in either patient group, indicating the potential for further weight loss beyond 52 weeks. MariTide was taken monthly or even less frequently in the trial, which could offer an advantage over the popular weekly injections on the market.
But Amgen shares fell about 10% on Tuesday as the results appear to be on the lower end of Wall Street's lofty expectations for the drug. Ahead of the data, several analysts said they wanted MariTide to show at least 20% weight loss in the phase two trial, with some expecting as much as 25%.
Wall Street has been anxiously awaiting the trial results, which shed light on how Amgen's drug may compare to the company's successful weight-loss injections. Nordisk and Eli Lilly and a crowded field of treatments developed by other drugmakers.
Amgen only released data on the first of two parts of the year-long trial, which was designed to test different dose sizes, schedules and regimens of MariTide. The main goal of the trial was to measure the amount of weight lost, but it also examined how long participants could go between injections and still lose pounds.
Notably, Amgen said patients who received the highest dose of MariTide every two months experienced weight loss comparable to those who took it monthly, suggesting the possibility of less frequent dosing of the drug.
About 11% of patients in the trial stopped treatment due to any adverse side effects, while less than 8% stopped specifically due to gastrointestinal side effects. Gastrointestinal side effects were mainly mild to moderate and were primarily associated with the first dose of the drug.
“Based on this data, we believe MariTide has a unique, differentiated and competitive profile, which we will explore in phase three of development,” Amgen CEO Robert Bradway said on a call with investors Tuesday after the results. .
The company will use the results from the first part “to put the fine details” into the design of its late-stage study on the treatment, which “is already in deep planning,” Amgen chief scientific officer Jay Bradner said in a statement. a previous interview. this month.
Amgen has said MariTide could offer faster weight loss, possibly better weight maintenance and fewer injections than weekly injections like Novo Nordisk's Wegovy and Eli Lilly's Zepbound. That could increase Amgen's chances of gaining a share of the weight-loss drug market, which some analysts predict could be worth $150 billion a year by the early 2030s.
Late-stage studies on Wegovy showed that it led to 15% weight loss in 68 weeks, while Zepbound helped patients lose more than 22% of their weight in 72 weeks.
MariTide brings a new approach to weight loss compared to existing 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 an intestinal hormone called GLP-1, while the antibody blocks receptors for another hormone called the GIP hormone.
This is different from Eli Lilly's anti-obesity drug, Zepbound, which activates both GIP and GLP-1. Wegovy activates GLP-1 but does not target GIP, which can also affect how the body breaks down sugar and fat.
“MariTide's synergistic molecular design requires only a fraction of the peptide delivery with fewer injections and fewer devices compared to weekly injectable alternatives,” Bradner said on Tuesday's call.
Amgen shares have soared this year in anticipation of midterm test data. That rally lost steam in recent weeks when one analyst raised questions about MariTide's potential bone density side effects. Amgen has said it is not concerned about MariTide's bone density data.
Test design
The first part of the phase two trial followed 592 patients, including 465 patients with obesity and 127 with obesity and type 2 diabetes. The trial examined MariTide in 11 different patient groups, where researchers tested a variety of regimens and dosing levels : 140, 280 and 420 milligrams.
For example, some groups used rapid dose escalation, which refers to starting patients on a lower dose of MariTide and gradually increasing it over four weeks until a higher target dose is reached. Others had a slower dose escalation over 12 weeks.
Several groups took MariTide once a month, while one group took the highest dose of the drug every two months. In an interview, Bradner noted that “patients with type 2 diabetes are known to respond less favorably to weight-loss medications,” so Amgen did not include them in any groups that used increased dose or lower dosing regimens. frequent.
More than 90% of eligible patients agreed to participate in the second part of the trial, which examines how long-lasting weight loss from MariTide is. The company is “interested in seeing how quickly people who lost weight recover when they stop the drug,” Bradner said in the interview.
The second part of the trial also evaluates any progressive weight loss after the initial year on MariTide and tests even less frequent dosing of the drug. Amgen has not said when it will release data from the second part of the trial.
Patients who continued the trial were randomly classified into several groups.
For example, patients who took 140 milligram doses of MariTide in the first part of the trial will continue taking that dose or switch to a placebo for another year, which will measure the duration of weight loss from MariTide. 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 a quarterly schedule among some patients who took 420-milligram doses in the first part of the trial. That means patients will receive a shot once every 12 weeks.
