Amgen has spoken out about concerns related to bone mineral density (BMD) loss with its obesity candidate after an analyst’s comment caused a $12bn market wipe.
The company has tried to lay to rest any investor concerns after a Cantor Fitzgerald analyst raised the alarm about MariTide (maridebart cafraglutide, formerly AMG 133) on Tuesday (12 November).
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In a statement released yesterday (13 November), an Amgen spokesperson said: “As previously stated, Amgen does not see an association between the administration of MariTide and bone mineral density changes. The Phase I study results do not suggest any bone safety concern or change our conviction in the promise of MariTide.”
Amgen added that it is still on track to release Phase II data (NCT05669599) before the end of the year.
The Cantor analyst, Olivia Brayer, highlighted previously unshared data, alleging that MariTide resulted in BMD at the highest dose. According to the analyst and as reported by Street Insider, ‘hidden figures’ found in an Excel spreadsheet of the trial data seemed to indicate a 4% drop in BMD in patients treated with the 420mg dose of MariTide over 12 weeks.
While lowered bone density can result in bone fractures and conditions like osteoporosis, the finding was not mentioned in Amgen’s early Phase I trial data (NCT04478708) on the drug published in Nature Metabolism in February 2024.
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By GlobalDataMariTide is a bispecific antibody that conjugates a gastric inhibitory polypeptide (GIP) antagonist with two glucagon-like peptide 1 (GLP-1) agonising peptides.
Brayer called the BMD data finding a ‘big unknown’ and risk given MariTide’s antagonist mechanism.
“On one hand, patients could naturally lose BMD during weight loss treatment,” Brayer said.
“On the other hand, this could be a non-starter because there seems to be a dose-dependent increase in BMD loss,” she concluded.
The analyst’s comment caused the company’s share price to drop by 7%, wiping $12 billion off the biotech’s market cap, however after Amgen released its statement, there was some recovery, with the stock price up 3.6%.
Jefferies analyst Michael Yee seemed unconcerned by the link and described the finding as a ‘non-issue’.
Early data from Amgen’s randomised, double-blind, placebo-controlled Phase I trial of MariTide in patients with obesity found that it had an acceptable safety and tolerability profile along with pronounced dose-dependent weight loss. In the multiple ascending dose cohorts, weight loss was maintained for up to 150 days after the last dose, with the 420mg dose resulting in body weight reduction of −14.5% by day 85.
The obesity drug market is currently dominated by GLP-1 receptor agonists (GLP-1ra’s), with Eli Lilly’s Mounjaro (tirzepatide) and Novo Nordisk’s Wegovy (semaglutide) the frontrunners. According to GlobalData analysis, the obesity drug market is forecast to reach a valuation of $37.1bn by 2031.
GlobalData is the parent company of Clinical Trials Arena.
