The Amgen emblem is displayed exterior Amgen headquarters in Thousand Oaks, California, on Might 17, 2023.
Mario Tama | Getty Pictures
Amgen on Tuesday mentioned its experimental weight reduction injection helped sufferers with weight problems lose as much as 20% of their weight on common after a yr in a essential mid-stage trial, as the corporate races to affix the booming weight problems drug market.
The drug, MariTide, additionally helped sufferers with weight problems and Sort 2 diabetes lose as much as 17% of their weight after a yr. The corporate mentioned it didn’t observe a plateau in both group of sufferers, which signifies the potential for additional weight reduction past 52 weeks. MariTide was taken month-to-month and even much less steadily within the trial — which may supply a bonus over the favored weekly injections in the marketplace.
However shares of Amgen fell roughly 11% in premarket buying and selling Tuesday, because the outcomes seem like on the decrease finish of Wall Road’s lofty expectations for the drug. Forward of the info, a number of analysts mentioned they wished MariTide to point out weight lack of not less than 20% within the section two trial, with some hoping for as much as 25%.
Wall Road has been eagerly awaiting the trial outcomes, which make clear how Amgen’s drug might measure as much as blockbuster weight reduction injections from Novo Nordisk and Eli Lilly and a crowded subject of remedies being developed by different drugmakers.
Amgen solely launched information on the primary of two year-long elements of the trial, which was designed to check completely different dose sizes, schedules and regimens of MariTide. The trial’s predominant purpose was to measure the quantity of weight reduction, but it surely additionally examined how lengthy individuals may go between injections and nonetheless lose kilos.
Notably, Amgen mentioned sufferers who obtained the very best dose of MariTide each different month skilled comparable weight reduction to those that took it month-to-month, suggesting the potential for much less frequent dosing of the drug.
Roughly 11% of sufferers within the trial discontinued therapy due to any antagonistic unintended effects, whereas lower than 8% stopped particularly because of gastrointestinal unintended effects. Gastrointestinal unintended effects had been primarily delicate to average and primarily related to the primary dose of the drug.
“Primarily based on these information, we imagine MariTide has a novel differentiated and aggressive profile, which we are going to discover in section three growth,” Amgen CEO Robert Bradway mentioned on a name with traders Tuesday after the outcomes.
The corporate will use the outcomes of the primary half “to place the high quality particulars” on the design of its late-stage examine on the therapy, which is “already deep into planning,” Amgen Chief Scientific Officer Jay Bradner mentioned in an interview earlier this month.
Amgen has mentioned MariTide may supply faster weight reduction, probably higher weight upkeep and fewer pictures than weekly injections akin to Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. That would increase Amgen’s odds of profitable a slice of the load loss drug market, which some analysts forecast could possibly be value $150 billion a yr by the early 2030s.
Late-stage research on Wegovy confirmed that it led to fifteen% weight reduction over 68 weeks, whereas Zepbound helped sufferers lose greater than 22% of their weight over 72 weeks.
MariTide brings a brand new method to weight reduction in comparison with the present medication in the marketplace 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 hormone.
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.
“MariTide’s synergistic molecular design requires solely a fraction of the peptide provide with fewer injections and fewer units versus weekly injectable alternate options,” Bradner mentioned on the Tuesday name.
Shares of Amgen have soared this yr in anticipation of the mid-stage trial information. That rally misplaced steam in latest weeks as one analyst raised questions on MariTide’s potential unintended effects associated to bone density. Amgen has mentioned it has no considerations about MariTide’s bone density information.
Trial design
The primary a part of the section two trial adopted 592 sufferers, together with 465 sufferers with weight problems and 127 with each weight problems and Sort 2 diabetes. The trial examined MariTide throughout 11 completely different affected person teams, the place researchers examined a wide range of regimens and dosing ranges – 140, 280 and 420 milligrams.
For instance, some teams used a fast dose escalation, which refers to beginning sufferers at a decrease dose of MariTide and regularly rising it over 4 weeks till they reached a better goal dose. Others had a slower dose escalation over 12 weeks.
A number of teams took MariTide as soon as a month, whereas one group took the very best dose of the drug each different month. In an interview, Bradner famous that Sort 2 diabetes sufferers are “identified to reply much less favorably to weight reduction medicines,” so Amgen didn’t put them in any teams that used dose escalation or much less frequent dosing regimens.
Greater than 90% of eligible sufferers agreed to take part within the second a part of the trial, which examines how sturdy MariTide’s weight reduction is. The corporate is ” to see how shortly individuals who misplaced weight rebound once they come off the drugs,” Bradner mentioned within the interview.
The second a part of the trial additionally evaluates any progressive weight reduction after the preliminary yr on MariTide and checks even much less frequent dosing of the drug. Amgen has not mentioned when it would launch information from the second a part of the trial.
Sufferers who continued the trial had been randomly sorted into a number of teams.
For instance, sufferers who took 140-milligram doses of MariTide within the first a part of the trial will both proceed taking that dose or change to a placebo for an additional yr, which can measure how long-lasting MariTide’s weight reduction is. Some individuals who took 280-milligram doses within the first a part of the trial will take decrease doses of the drug for a yr.
Amgen can be testing a quarterly schedule amongst some sufferers who took 420-milligram doses within the first a part of the trial. Meaning sufferers will get a shot as soon as each 12 weeks.
