In line with Amgen, the anti-obesity drug resulted in weight reduction of as much as 20% after one yr without plateauing

Amgen said Tuesday that its experimental weight-loss injection has helped patients with obesity drop some pounds as much as 20% of their weight on average after a yr in a critical mid-stage trial as the corporate struggles to enter the booming obesity drug market.

The drug MariTide also helped patients with obesity and kind 2 diabetes lose as much as 17% of their weight after one yr. The company said it didn’t observe a plateau in any of the patient groups, indicating the potential for further weight reduction beyond week 52. MariTide was taken monthly and even less steadily within the study – which could offer a bonus over the favored weekly injections available on the market.

But Amgen shares fell about 5% on Tuesday as results seemed to be on the low end of Wall Street's lofty expectations for the drug. Ahead of the information release, several analysts said they wanted MariTide to point out at the least 20% weight reduction within the Phase 2 trial, with some hoping for as much as 25%.

Wall Street has been eagerly awaiting the outcomes of the study, which can make clear how Amgen's drug competes with blockbuster weight-loss injections Novo Nordisk And Eli Lilly and a crowded field of treatments being developed by other drugmakers.

Jared Holz, healthcare equity strategist at Mizuho, ​​said in an email Tuesday: “We feel investors have even more confidence in Eli Lilly and Novo Nordisk as leaders in the weight loss drug market.” He noted that Amgen could potentially be a “distant third/fourth player” on this space, as MariTide likely won't come to market until around 2027.

Amgen only released data on the primary of two yearlong parts of the study, which tested different dose sizes, schedules and treatment regimens of MariTide. The fundamental goal of the study was to measure the extent of weight reduction, nevertheless it also checked out how long participants could go between injections and still lose kilos.

Specifically, Amgen said patients who received the best dose of MariTide every two months experienced comparable weight reduction to those that took it monthly, suggesting the potential for less frequent dosing of the drug.

Approximately 11% of patients within the study discontinued treatment as a result of hostile negative effects, while lower than 8% discontinued treatment specifically as a result of gastrointestinal negative effects. Gastrointestinal negative effects were predominantly mild to moderate and were primarily related to the primary dose of the drug.

Amgen said dose escalation, during which patients start with a lower dose of MariTide and steadily increase it until they reach the next goal dose, significantly improved the frequency of those negative effects within the study.

“Based on this data, we believe MariTide has a unique, differentiated and competitive profile that we will explore in the third phase of development,” Amgen CEO Robert Bradway said on a post-earnings call with investors on Tuesday.

The company will use the outcomes of the primary part to “determine the fine details” of the design of its late-stage trial of the treatment, which is “already deep in planning,” Amgen Chief Scientific Officer Jay Bradner said earlier in an announcement Interview this month.

Amgen said MariTide could provide faster weight reduction, potentially higher weight maintenance and fewer injections than weekly injections equivalent to Novo Nordisk's Wegovy and Eli Lilly's Zepbound. That could boost Amgen's possibilities of capturing among the weight-loss drug market, which some analysts predict price $150 billion per yr until the early 2030s.

Later studies of Wegovy showed that it resulted in 15% weight reduction inside 68 weeks, while Zepbound helped patients lose greater than 22% of their weight inside 72 weeks.

MariTide offers a brand new approach to weight reduction in comparison with drugs already available on the market since it is a so-called peptide-antibody conjugate, which is a monoclonal antibody sure 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.

This is different than Eli Lilly's obesity drug Zepbound, which prompts each GIP and GLP-1. Wegovy prompts GLP-1 but doesn’t goal GIP, which may affect how the body breaks down sugar and fat.

“MariTide's synergistic molecular design requires only a fraction of the peptide supply with fewer injections and fewer devices compared to weekly injectable alternatives,” Bradner said on Tuesday's conference call.

Amgen shares have risen this yr in anticipation of midterm study data. That rally lost steam in recent weeks when an analyst raised questions on MariTide's possible negative effects related to bone density. Amgen has stated that it has no concerns about MariTide's bone density data.

The first a part of the phase 2 study examined 592 patients, including 465 patients with obesity and 127 patients with obesity and kind 2 diabetes. The study examined MariTide in 11 different patient groups, with researchers testing different treatment regimens and dosage levels – 140, 280 and 420 milligrams.

For example, some groups used rapid dose escalation, during which patients were began on a lower dose of MariTide and steadily increased over 4 weeks until they reached the next goal dose. Others experienced a slower dose increase over 12 weeks.

Several groups took MariTide once a month, while one group took the best dose of the drug every two months. In an interview, Bradner identified that patients with type 2 diabetes “are known to respond less favorably to weight loss medications,” which is why Amgen didn’t assign them to a bunch that used dose escalations or less frequent dosing schedules.

More than 90% of eligible patients agreed to take part in the second a part of the study, which can examine how durable MariTide's weight reduction is. The company is “interested in seeing how quickly people who have lost weight regain their strength after stopping the medication,” Bradner said within the interview.

The second a part of the study may even assess progressive weight reduction after the primary yr of taking MariTide and test much more infrequent dosing of the drug. Amgen has not said when it’ll release data from the second a part of the trial.

Patients who continued the study were randomly divided into several groups.

For example, patients who took 140-milligram doses of MariTide in the primary a part of the study will either proceed taking that dose or switch to a placebo for an additional yr, which can measure how long MariTide weight reduction lasts. Some individuals who took 280-milligram doses in the primary a part of the study will take lower doses of the drug for a yr.

Amgen can also be testing a quarterly schedule in some patients who took 420-milligram doses in the primary a part of the study. This implies that patients receive a vaccination every 12 weeks.