Zinger Key Points
- MariTide achieved up to ~20% weight loss at 52 weeks without a plateau, with cardiometabolic improvements.
- GI side effects were common, leading to ~11% discontinuation rate, but no bone mineral density changes or new safety concerns were reported.
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On Tuesday, Amgen Inc AMGN stock fell during the premarket session after the company released long-anticipated data from the Phase 2 study of MariTide (maridebart cafraglutide, formerly AMG 133) in obese patients.
The company said that MariTide demonstrated up to ~20% average weight loss at one year (52 weeks) without a weight loss plateau, indicating the potential for further weight loss beyond 52 weeks.
Amgen’s stock dropped as the results seemed to fall short of Wall Street’s high expectations. CNBC noted that analysts had hoped MariTide would achieve at least 20% weight loss in the Phase 2 trial, with some aiming for as much as 25%.
The study also showed that a subset of patients who typically lose less weight on GLP-1 therapies achieved up to ~17% average weight loss without a weight loss plateau, lowering their average hemoglobin A1C (HbA1c) by up to 2.2 percentage points at week 52.
MariTide also demonstrated improvements in cardiometabolic parameters, including blood pressure, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) across doses. There were no significant increases in free fatty acids.
There was no association between the administration of MariTide and bone mineral density changes.
The most common side effects were gastrointestinal, including vomiting, nausea, and constipation. Amgen said the discontinuation rate in the dose escalation arms due to any AE was ~11% and less than 8% for GI-related events. No additional safety signals were identified.
In a separate ongoing Phase 1 pharmacokinetic study, additional dosing regimens have been evaluated in a planned preliminary analysis.
The ongoing Part 2 of the Phase 2 study is investigating MariTide beyond 52 weeks to evaluate further weight loss with continued treatment, weight maintenance through less frequent or lower dosing and durability of weight loss after discontinuation of MariTide.
MariTide is expected to be delivered as a single dose in a handheld, autoinjector device with a monthly or less frequent single-injection administration.
Amgen is also advancing its obesity pipeline, including oral and injectable approaches composed of incretin and non-incretin mechanisms.
Price Action: AMGN stock is down 11.6% at $259.88 during the premarket session at last check Tuesday.
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