On Tuesday, a Cantor analyst wrote that additional data from Amgen’s experimental weight loss injection, MariTide, suggests a new potential safety risk tied to the drug.
On Wednesday, Amgen Inc AMGN stated the MariTide (maridebart cafraglutide, formerly AMG 133) Phase 1 data, saying, “Amgen does not see an association between the administration of MariTide and bone mineral density (BMD) changes. The Phase 1 study results do not suggest any bone safety concerns or change our conviction in the promise of MariTide. We look forward to sharing the Phase 2 topline data later this year.”
CNBC highlighted that MariTide could be a strong new contender in the weight loss drug market. Unlike current weekly injections from Novo Nordisk A/S NVO and Eli Lilly And Co LLY, MariTide is taken once a month and works through a different mechanism.
Analysts referred to new public data from a phase one study, showing that the highest dose of MariTide (420 milligrams) was associated with around 4% decrease in bone mineral density over 12 weeks.
Goldman Sachs responded that after reviewing the data, they do not believe it shows any safety issues.
Goldman Sachs says BMD measurements from DEXA scans and believes concerns about the data are not justified as there is no significant difference between the treatment and placebo, nor any clear dose-dependent effect in the DEXA data.
The analyst also says a study by Amgen’s deCODE genetics, which included data from 1.2 million people, found no link between obesity-related variants in the GIPR gene and a higher risk of fractures or lower BMD. It’s already well-established that rapid weight loss is linked to BMD loss.
William Blair notes that at lower doses of AMG 133 (140 mg and 280 mg), the reduction in bone mineral density 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 stands out compared to typical reductions of 2% to 2.5%, bariatric surgery has been known to reduce BMD by 3% to 5% after six months.
MariTide, which leads to more significant weight loss over six months than semaglutide or liraglutide, may also result in greater BMD reductions due to this weight change.
Price Action: AMGN stock is up 1.39% at $302.98 at last check Wednesday.
Photo via Shutterstock
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