Amgen said on Wednesday that it’s so no link between its experimental weight-loss drug, MariTide, and changes in bone density, a day after those potential safety concerns knocked greater than $12 billion off its market value.
The company's shares fell greater than 7% on Tuesday as analysts examined data on bone density loss from an early trial of the shot. An analyst said the extra data suggests a brand new potential safety risk related to the drug. But others said the stock move was an overreaction and that more data on a bigger patient population was needed.
In an announcement Wednesday, Amgen said: “The Phase 1 trial results do not indicate any bone safety concerns or change our belief in the promise of MariTide.” The drugmaker added that it looks forward to being the primary Phase 2 trial results for the treatment will probably be announced later this 12 months.
Shares of the corporate rose greater than 1% on Wednesday.
The drug is a promising potential competitor in the load loss drug market. It is designed to be taken monthly, relatively than once per week, as is the case with previous injections Novo Nordisk And Eli Lillyand promotes weight reduction in a different way.
Analysts on Tuesday cited additional publicly available data from a Phase 1 trial showing that the best dose of MariTide – 420 milligrams – was related to a loss in bone mineral density of about 4% over a 12-week period. A decrease in bone mineral density means the bones lose calcium and other minerals, making them weaker and increasing the likelihood of fracture.
In a research note, Cantor-Fitzgerald analyst Olivia Brayer called the information a “big unknown” and suggested it may very well be a possible risk related to drugs like MariTide, which work through so-called GIPR antagonism. Amgen's injection blocks a gut hormone receptor called GIP but additionally prompts one other appetite-stimulating hormone called GLP-1.
This is different than Eli Lilly's obesity drug Zepbound, which prompts GIP and GLP-1. Wegovy prompts GLP-1 but doesn’t goal GIP, which can even affect how the body breaks down sugar and fat.
“On the one hand, patients may naturally lose bone mineral density during weight loss treatment,” Brayer wrote.
But Brayer said, “On the other hand, this could be a failure because there appears to be a dose-dependent increase” in bone mineral density loss. This implies that the upper the dose patients take, the more bone mineral density they seem to lose.
Meanwhile, Jefferies analyst Michael Yee wrote in a note that the extra MariTide data appears to be “a non-issue.” Yee acknowledged that there was a decrease in bone density in individuals who took the best dose of the drug, but said, “The data is patchy.”
For example, he pointed to data on a lower dose of the drug that showed bone density actually increased by 1% before normalizing. Yee added that “changes” in bone mineral density are a known side effect of weight-loss medications in the primary one to a few months of use, as people lose significant weight quickly.
Amgen can be aware of the “hypothetical concern” about lack of bone mineral density, Yee said, citing the corporate's discussions with management.
“While we are of course not saying there is no impact, what we are saying is that we do not believe there is a significant problem.” [bone mineral density] “Overall, we don’t think there is a problem and the effect will normalize over time.”
BMO analyst Evan Seigerman wrote in a note Tuesday: “We would be cautious in making a comprehensive judgment about MariTide's safety profile based on this data.”
He added: “It would be easier for us to assess the safety profile on a larger cohort of patients.” There will not be a transparent answer until Amgen releases full Phase 2 trial data on the drug.
“This has not changed our opinion of MariTide and we consider the sale to be excessive,” Seigerman wrote.
image credit : www.cnbc.com