The Amgen logo is displayed outside Amgen’s headquarters in Thousand Oaks, California, on May 17, 2023.
Mario Tama | Getty Images
Amgen On Tuesday it said it was experimental weight loss injections Help obese patients lose weight Up to 20% of body weight On average, after a year of key mid-stage trials, companies race to join the booming market obesity drug market.
The drug, MariTide, can also help people with obesity and type 2 diabetes lose up to 17 percent of their body weight after one year. The company said no plateau was observed in either group, suggesting further weight loss may be possible after 52 weeks. MariTide is administered as monthly or even less frequent injections in trials, which may have advantages over the weekly injections popular on the market.
But Amgen shares fell about 11% in premarket trading Tuesday as the results appeared to fall short of Wall Street’s lofty expectations for the drug. Ahead of the data, several analysts said they expected MariTide to show at least 20% weight loss in Phase 2 trials, with some hoping for 25%.
Wall Street has been eagerly awaiting trial results that will reveal how Amgen’s drug stacks up against blockbuster weight loss shots. Novo Nordisk and Eli Lilly and Company Other drugmakers are developing a crowded therapeutic area.
Amgen has released data only from the first part of the two-year trial, which is designed to test different dose sizes, schedules and regimens of MariTide. The trial’s main goal was to measure the extent of weight loss, but it also examined how long participants could go between injections and still lose weight.
Notably, Amgen said patients who received the highest dose of MariTide every other month lost as much weight as those who received it once a month, suggesting the drug may be administered less frequently.
Approximately 11% of patients in the trial discontinued treatment due to any adverse side effects, while less than 8% discontinued treatment specifically due to gastrointestinal side effects. Gastrointestinal side effects were mainly mild to moderate and were mainly related to the first dose of the drug.
“Based on these data, we believe MariTide has unique differentiation and competitive advantages that we will continue to develop in This is being explored in the third phase of development.”
Amgen Chief Scientific Officer Jay Bradner said earlier in an interview that the company will use the results from the first part “to provide details for the design of a later-stage study of the treatment,” which is “already deeply in planning.” “this month.
Amgen said MariTide can lead to faster weight loss, potentially better weight maintenance and requires fewer injections than weekly injections like Novo Nordisk’s Wegovy and Eli Lilly and Company’s Zepbound. That could improve Amgen’s chances of winning share in the weight-loss drug market, which some analysts predict could be worth $150 billion annually By the early 2030s.
Late-stage studies of Wegovy showed it resulted in a 15% weight loss over 68 weeks, while Zepbound helped patients lose more than 22% of their weight over 72 weeks.
MariTide brings a new approach to weight loss compared to existing drugs on the market, as 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 antibodies block receptors for another hormone called GIP hormone.
This is different from Eli Lilly’s obesity drug Zepbound, which activates both GIP and GLP-1. Wegovy activates GLP-1, but not GIP, which may also affect how the body breaks down sugar and fat.
“MariTide’s synergistic molecular design requires only a fraction of the peptide supply and requires fewer injections and less equipment than alternatives that require weekly injections,” Bradner said during a conference call Tuesday.
Amgen’s shares have soared this year on expectations of interim trial data. The rally has lost steam in recent weeks as one analyst cast doubt on MariTide’s potential Side effects related to bone density. Amgen said it was not concerned about MariTide’s bone density data.
experimental design
The first part of the Phase 2 trial followed 592 patients, including 465 obese patients and 127 patients with both obesity and type 2 diabetes. The trial examined MariTide in 11 different patient groups, with researchers testing various treatment regimens and dose levels (140, 280 and 420 mg).
For example, some groups use rapid dose escalation, which starts patients on a lower dose of MariTide and then gradually increases the dose over four weeks until a higher target dose is reached. Others slowly increase the dose over 12 weeks.
Several groups took MariTide once a month, while one group took the highest dose of the drug every other month. Bradner noted in an interview that patients with type 2 diabetes are “known to respond less well to weight-loss drugs,” so Amgen did not place them in any group using an escalating dose or less frequent dosing regimen.
More than 90% of eligible patients agreed to participate in the second part of the trial, which examined how long-lasting the weight loss effects of MariTide were. Bradner said in an interview that the company was “interested in understanding how quickly people regain weight after they stop taking the drug.”
The second part of the trial also assessed progressive weight loss after the first year of MariTide use and tested even less frequent doses 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 divided into groups.
For example, patients who took a 140-mg dose of MariTide in the first part of the trial will either continue taking that dose or switch to a placebo for one year, which will measure how long-lasting MariTide’s weight loss effects are. Some people who took the 280 mg dose in the first part of the trial will take the lower dose for a year.
Amgen is also testing a quarterly schedule in some patients taking the 420 mg dose in the first part of the trial. This means patients will receive injections every 12 weeks.
