Amgen’s MariTide, a potential game-changer in the weight loss drug market, has faced a bump in the road. On Tuesday, a Cantor analyst raised concerns about a potential safety risk associated with the drug, highlighting data from a Phase 1 study that indicated a decrease in bone mineral density (BMD) at the highest dose of MariTide.
This news sent ripples through the market, causing Amgen’s stock to dip. However, the company swiftly responded on Wednesday, stating that it does not see a correlation between MariTide administration and BMD changes. They emphasized that the Phase 1 study results do not suggest any bone safety concerns and remain confident in the drug’s potential.
The analyst’s concerns stemmed from data showing a roughly 4% decrease in BMD over 12 weeks at the highest dose (420 milligrams) of MariTide. However, Goldman Sachs, after reviewing the data, concluded that it does not reveal any safety issues. They pointed to DEXA scan measurements and argued that the concerns are not justified, as there’s no significant difference between the treatment and placebo groups, nor a clear dose-dependent effect in the DEXA data.
Further supporting Amgen’s stance, the analyst also referenced a study by Amgen’s deCODE genetics involving 1.2 million individuals, which found no link between obesity-related variants in the GIPR gene and an increased risk of fractures or lower BMD.
It’s important to note that rapid weight loss is known to be associated with BMD loss. William Blair analysts pointed out that at lower doses of MariTide (140 mg and 280 mg), the BMD reduction is minimal, around 2% at most, which might not differ significantly from the placebo due to limited data in smaller groups. While the 4% reduction at the highest dose stands out compared to typical reductions of 2% to 2.5%, it’s worth noting that bariatric surgery, a more invasive weight loss procedure, has been known to reduce BMD by 3% to 5% after six months. As MariTide leads to more significant weight loss over six months than semaglutide or liraglutide, it could also result in greater BMD reductions due to this weight change.
Despite the initial concerns, Amgen’s stock has recovered, closing up 1.39% on Wednesday. The company remains optimistic about MariTide’s potential, and analysts continue to see it as a strong contender in the weight loss drug market, given its once-a-month administration and unique mechanism of action.
