The Amgen logo is displayed outside Amgen headquarters in Thousand Oaks, California, on May 17, 2023.
Mario Tama | Getty Images
Amgen on Tuesday said its experimental weight reduction injection helped patients with obesity lose as much as 20% of their weight on average after a yr in a critical mid-stage trial, as the corporate races to affix the booming obesity drug market.Â
The drug, MariTide, also helped patients with obesity and Type 2 diabetes lose as much as 17% of their weight after a yr. The corporate said it didn’t observe a plateau in either group of patients, which indicates the potential for further weight reduction beyond 52 weeks.
But shares of the corporate fell roughly 5% in premarket trading Tuesday, as the outcomes seem like on the low end of Wall Street’s expectations. Ahead of the information, several analysts said they expected MariTide to indicate weight reduction of a minimum of 20% within the phase two trial, with some hoping for as much as 25%.Â
Wall Street has been eagerly awaiting the phase two trial results, which make clear how Amgen’s drug may measure as much as blockbuster weight reduction injections from Novo Nordisk and Eli Lilly and a crowded field of treatments being developed by other drugmakers.
Amgen only released data on the primary of two year-long parts of the trial, which was designed to check different dose sizes, schedules and regimens of MariTide. The corporate will use the outcomes of the primary part “to place the high quality details” on the design of its late-stage study on the treatment, which is “already deep into planning,” Amgen Chief Scientific Officer Jay Bradner said in an interview earlier this month.Â
Amgen has said MariTide could offer quicker weight reduction, possibly higher weight maintenance and fewer shots than weekly injections comparable to Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. That might boost Amgen’s odds of winning a slice of the load loss drug market, which some analysts forecast might be price $150 billion a yr by the early 2030s.
Late-stage studies on Wegovy showed that it led to fifteen% weight reduction over 68 weeks, while Zepbound helped patients lose greater than 22% of their weight over 72 weeks.Â
MariTide brings a latest approach to weight reduction in comparison with the prevailing drugs available on the market since it is a so-called peptide antibody conjugate, which refers to a monoclonal antibody linked to 2 peptides. The peptides activate receptors of a gut hormone called GLP-1, while the antibody blocks receptors of one other hormone called GIP hormone.Â
That is unlike Eli Lilly’s obesity drug, Zepbound, which prompts each GIP and GLP-1. Wegovy prompts GLP-1 but doesn’t goal GIP, which can also affect how the body breaks down sugar and fat.
Shares of Amgen have soared this yr in anticipation of the mid-stage trial data. That rally lost steam in recent weeks as one analyst raised questions on MariTide’s potential uncomfortable side effects related to bone density.
Trial design, data
The primary a part of the phase two trial followed 592 patients, including 465 patients with obesity and 127 with each obesity and Type 2 diabetes. The trial examined MariTide across 11 different patient groups, where researchers tested quite a lot of regimens and dosing levels – 140, 280 and 420 milligrams.Â
For instance, some groups used a fast dose escalation, which refers to starting patients at a lower dose of MariTide and steadily increasing it over 4 weeks until they reached the next goal dose. Others had a slower dose escalation over 12 weeks.Â
Several groups took MariTide once a month, while one group took the very best dose of the drug every other month. Bradner noted that Type 2 diabetes patients are “known to reply less favorably to weight reduction medicines,” so Amgen didn’t put them in any groups that used dose escalation or less frequent dosing regimens.Â
Amgen invited patients to take part in the second a part of the trial, which examines how durable MariTide’s weight reduction is. The corporate is “interested to see how quickly individuals who lost weight rebound once they come off the medication,” Bradner said.Â
The second a part of the trial also evaluates any progressive weight reduction after the initial yr on MariTide and tests even less frequent dosing of the drug. Amgen has not said when it’s going to release data from the second a part of the trial.
Patients who continued the trial were randomly sorted into several groups.Â
For instance, patients who took 140-milligram doses of MariTide in the primary a part of the trial will either proceed taking that dose or switch to a placebo for one more yr, which can measure how long-lasting MariTide’s weight reduction is. Some individuals who took 280-milligram doses in the primary a part of the trial will take lower doses of the drug for a yr.Â
Amgen can be testing a quarterly schedule amongst some patients who took 420-milligram doses in the primary a part of the trial. Which means patients will get a shot once every 12 weeks.Â
