The Amgen emblem is displayed exterior Amgen headquarters in Thousand Oaks, California, on Might 17, 2023.
Amgen on Wednesday stated it has began two vital late-stage trials for its experimental weight reduction injection MariTide, one other step in its bid to enter the booming weight problems drug market.
“We’re delighted to share that these trials have now been initiated, and actually, the development of the MARITIME program goes very, very nicely,” Dr. Jay Bradner, Amgen’s government vice chairman of analysis and improvement, stated in the course of the TD Cowen convention, utilizing the identify of the drug’s part three improvement program.
MariTide is a month-to-month injection that buyers hope may compete in opposition to present weight reduction medication from Novo Nordisk and Eli Lilly, that are weekly injectables. They’re a part of a category of medicine known as GLP-1s, which mimic sure hormones produced within the intestine to tamp down urge for food and regulate blood sugar.
About 6% of U.S. adults, or greater than 15 million individuals, have been utilizing a prescription for GLP-1s as of Might, based on a survey from well being coverage group KFF. Some analysts anticipate the marketplace for GLP-1s to be price greater than $150 billion yearly by the early 2030s.
One of many new part three trials is inspecting Amgen’s drug in round 3,500 individuals with weight problems or who’re chubby with out Sort 2 diabetes, Bradner stated. The second examine examines MariTide in 999 sufferers who’re overweight or chubby and have Sort 2 diabetes
The principle purpose of each research is to measure the proportion of weight reduction at 72 weeks. Amgen will examine three goal doses of MariTide and plans to make use of dose escalation, or beginning sufferers at a decrease dose of the drug and growing that quantity over time. The corporate didn’t share a selected routine for dosing within the trials.
Amgen in November stated MariTide helped sufferers with weight problems lose as much as 20% of their weight on common after a 12 months in a part two trial, with no weight reduction plateau. The drug additionally helped sufferers with weight problems and Sort 2 diabetes lose as much as 17% of their weight after a 12 months with no plateau. However the outcomes have been on the decrease finish of Wall Avenue’s lofty expectations for the drug.
Amgen will report extra information on MariTide this 12 months. The complete outcomes of the part two trial can be offered on the American Diabetes Affiliation convention in June. The corporate can also be persevering with to check sufferers in an extension of that trial that may learn out within the second half of this 12 months.
MariTide brings a brand new strategy to weight reduction in contrast with the prevailing medication available on the market as a result of it’s a so-called peptide antibody conjugate, which refers to a monoclonal antibody linked to 2 peptides. The peptides activate receptors of a intestine hormone known as GLP-1, whereas the antibody blocks receptors of one other hormone known as GIP.
That is in contrast to Eli Lilly’s weight problems drug, Zepbound, which prompts each GIP and GLP-1. Wegovy prompts GLP-1 however doesn’t goal GIP, which can additionally have an effect on how the physique breaks down sugar and fats.
