Amgen‘s share price has dropped despite announcing positive data from its Phase II MariTide (maridebart cafraglutide, formerly AMG 133) study, boasting 20% weight loss.
Data from the Phase II trial (NCT05669599) showed an average of 20% weight loss at 52 weeks for patients who are overweight or obese without type 2 diabetes (T2D).
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For patients with overweight or obesity and T2D (who usually lose less weight on GLP-1 therapies), an average of 17% weight loss was attained. The diabetic group also experienced a reduced average haemoglobin A1C (HbA1c) of up to 2.2 percentage points at week 52.
In both groups, patients did not experience a weight loss plateau, indicating the possibility of further weight loss beyond the 52-week mark.
Despite the positive results for MariTide, Amgen’s share price dropped 10% following the announcement, suggesting investors had hoped for better. The disappointment could be attributable in part to adverse events (AEs) in the dose escalation arms in the study, which saw around 11% of patients discontinue treatment.
The most commonly experienced AEs were related to gastrointestinal (GI) complications and included nausea, vomiting and constipation. Amongst the dose escalation arms, discontinuation as a result of GI-related adverse effects was less than 8%. Amgen described the AEs as “predominately mild to moderate, transient, and primarily associated with the first dose”. It said that nausea was generally resolved within a median window of six days, and vomiting in one to two days.
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By GlobalDataToday’s news represents the second blow for Amgen’s share prices this month. On 12 November, the company’s share price dropped 7.14% when a Cantor Fitzgerald analyst raised concerns about Phase I data found in a hidden tab, which suggested that MariTide negatively affected bone mineral density changes.
Sharing the Phase II study results during an investor call, Amgen briefly addressed the issue, reporting that there was “no association between the administration of MariTide and bone mineral density changes”.
Following today’s results, Amgen will continue with the second part of its Phase II study for MariTide, including patients who experienced a body weight reduction of over 15%. Of those patients, more than 90% chose to continue their participation. This part of the study will last another 52 weeks and will assess weight loss with continued treatment, weight maintenance through less frequent or lower dosing and durability of weight loss after discontinuation of MariTide.
Amgen also announced that it will launch MARITIME, a Phase III clinical development programme in obesity and obesity-related conditions.
“We are very excited by MariTide’s differentiated profile, with clinically meaningful attributes of substantial and progressive weight loss, monthly or less frequent dosing, significant improvements in cardiometabolic parameters and strong reduction of HbA1C,” said Jay Bradner, executive vice president of R&D and chief scientific officer at Amgen.
“These results provide us the confidence to initiate MARITIME, a Phase III programme across obesity and a number of related conditions, providing a unique potential new treatment option for patients.”
The company also reported that MariTide demonstrated clinically meaningful improvements in cardiometabolic parameters. These included blood pressure, triglycerides and high-sensitivity C-reactive protein (hs-CRP) across doses. There were no significant increases in free fatty acids.
There is a lot of competition in the weight loss field, predominantly due to Novo Nordisk‘s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide). The Phase II trial of Amgen’s candidate boasts similar efficacy data but, if approved, could be more attractive to patients due to its once-monthly dosing schedule.
