The Amgen logo is displayed outside Amgen’s headquarters in Thousand Oaks, California, on May 17, 2023.
Tama Mario | Getty Images
amgen The company aims to tap into the fast-growing obesity drug market, announcing Tuesday that its experimental weight loss injection reduced weight in obese patients by up to 20% on average after a year in a pivotal mid-term trial.
The drug Maritide also helped patients with obesity and type 2 diabetes lose up to 17% of their body weight after one year. The company said no plateau was observed in either patient group, indicating the potential for further weight loss beyond 52 weeks. Maritide was administered monthly or less frequently in the trial. This may offer advantages over weekly injections that are popular on the market.
However, Amgen’s stock price fell about 5% on Tuesday as the results appeared to be on the low end of Wall Street’s lofty expectations for the drug. Ahead of the data release, several analysts said they wanted Maritide to show at least 20% weight loss in Phase 2 trials, with some expecting up to 25%.
Wall Street has been waiting for trial results to reveal how effective Amgen’s drug is as a blockbuster weight-loss injection. novo nordisk and Eli Lilly and a crowded field of treatments being developed by other drug companies.
“Our sense is that investors are becoming more confident that Eli Lilly and Novo Nordisk are leaders in the weight loss drug market,” Jared Holtz, a healthcare equity strategist at Mizuho, said in an email Tuesday. ” he said. He noted that Amgen could become a “distant third/fourth player” in the space, as Maritide is likely to enter the market around 2027.
Amgen announced only data from the first part of a two-year trial designed to test different dose sizes, schedules and regimens of Maritide. While the primary goal of the trial was to measure weight loss, it also looked at how long participants could wait between injections and still lose weight.
Notably, Amgen says patients who received the highest doses of Maritide every other month experienced weight loss comparable to those who received monthly doses, suggesting that the drug may need to be administered less frequently. said.
Approximately 11% of patients in the trial discontinued treatment due to any adverse side effects, but less than 8% discontinued due to gastrointestinal side effects specifically. Gastrointestinal side effects were mainly mild to moderate and primarily related to the first dose of the drug.
Amgen said dose escalation, in which patients were started on a low dose of Maritide and gradually increased until reaching a higher target dose, significantly improved the incidence of side effects in the trial.
“Based on these data, we believe Maritide has a unique and differentiated competitive profile,” Amgen CEO Robert Bradway said on Tuesday’s post-earnings conference call with investors. “We believe there is, and we will explore that in the third phase of development.”
Jay Bradner, Amgen’s chief scientific officer, said in a previous interview that the company will use the results from Part 1 to advance late-stage research into the treatment. He said he plans to “work out the details” of the plan and that research is “already deep in the plan.” this month.
Amgen said Maritide may provide faster weight loss, possibly better weight maintenance, and fewer injections than weekly injections such as Novo Nordisk’s Wegoby and Eli Lilly’s Zepbound. Ta. This could increase Amgen’s chances of capturing a slice of the weight-loss drug market, which some analysts expect to be worth $150 billion a year by the early 2030s.
Wegovy’s late-stage studies showed that Zepbound led to 15% weight loss over 68 weeks, and Zepbound helped patients lose more than 22% of their body weight over 72 weeks.
MariTide is a so-called peptide-antibody conjugate, which refers to a monoclonal antibody linked to two peptides, and therefore brings a new approach to weight loss compared to existing drugs on the market. The peptide activates a receptor for a gut hormone called GLP-1, while the antibody blocks the receptor for another hormone called the GIP hormone.
This is different from Eli Lilly’s obesity drug Zepbound, which activates both GIP and GLP-1. Wegovy activates GLP-1 but does not target GIP. This can also affect how your body breaks down sugars and fats.
“MariTide’s synergistic molecular design requires fewer injections and fewer devices to deliver a fraction of the peptide compared to weekly injectable alternatives,” Bradner said on Tuesday’s conference call. said.
Amgen’s stock price soared this year on expectations for data from the trial. The rally lost steam in recent weeks as one analyst questioned Maritide’s potential side effects related to bone density. Amgen says it has no concerns about Maritide’s bone density data.
trial design
The first part of the Phase 2 study followed 592 patients, including 465 who were obese and 127 who had both obesity and type 2 diabetes. The trial investigated MariTide across 11 different patient groups, and researchers tested different regimens and dose levels (140, 280, and 420 milligrams).
For example, some groups used rapid dose escalation. This refers to starting patients on a low dose of maritide and gradually increasing the dose over 4 weeks until reaching a higher target dose. In other patients, dose escalation occurred more slowly over 12 weeks.
Some groups took MariTide once a month, while one group took the highest dose of the drug every other month. Bradner said in an interview that patients with type 2 diabetes “are known to not respond very well to weight-loss drugs,” so Amgen is placing patients in groups that use titration and less frequent dosing regimens. He said he could not enter.
More than 90% of eligible patients agreed to participate in the second part of the trial to determine how long MariTide’s weight loss effects last. The company is “interested in how quickly people who lose weight rebound when they stop taking the drug,” Bradner said in an interview.
The second part of the study will also evaluate progressive weight loss after the first year of using MariTide and also test 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 on the trial were randomly divided into several groups.
For example, patients who took 140 milligrams of Maritide in the first part of the trial will either continue taking that dose or switch to a placebo for another year, but this will determine how long Maritide’s weight loss lasts. It will be measured. Some people who took the 280-milligram dose in the first phase of the trial will take a lower dose of the drug for a year.
Amgen is also testing a quarterly schedule in some patients who received a 420-milligram dose in the first part of the trial. This means patients will be vaccinated once every 12 weeks.
