Amgen Inc AMGN announced on Monday the full results from Part 1 of the Phase 2 study of MariTide (maridebart cafraglutide, formerly AMG 133), a long-acting, peptide-antibody conjugate subcutaneously administered monthly or less frequently.
In the Phase 2 study, MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D) compared with 2.6% in the placebo arm and up to ~17% average weight loss in people living with obesity with T2D, compared with 1.4% in the placebo arm, per the efficacy estimand.
Weight loss had not plateaued by 52 weeks, indicating the potential for further weight reduction.
In addition to meaningful weight loss, MariTide demonstrated a robust and sustained reduction in hemoglobin A1c (HbA1c) of up to 2.2% in obese and T2D patients.
Also Read: Amgen’s Better Than Expected Q1 Earnings Take Backseat As Eyes Are On MariTide Obesity Data
Weight loss with MariTide was also accompanied by improvements across pre-specified cardiometabolic measures, including waist circumference, blood pressure, high-sensitivity C-reactive protein (hs-CRP) and select lipid parameters.
No new safety signals were identified in the Phase 2 study, and tolerability was consistent with that of the GLP-1 class. The most frequently reported adverse events (AEs) were gastrointestinal (GI) related, and most were mild to moderate.
In addition to these data, complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association and simultaneously published in The New England Journal of Medicine.
The complete primary analysis showed that participants who received 21 mg/70 mg/350 mg had an overall incidence of vomiting of 24.4%, and participants who received 35 mg/70 mg/350 mg had an overall incidence of vomiting of 22.5%. There were no discontinuations due to GI AEs during the study.
Data from the Phase 2 and Phase 1 PK-LDI MariTide studies informed the Phase 3 MARITIME program.
The company recently initiated the Phase 3 MARITIME program, a 72-week chronic weight management study that will evaluate the safety, efficacy, and tolerability of MariTide in participants living with obesity or overweight with and without Type 2 diabetes.
Participants will be randomized to one of three target doses, each with an initial starting dose of 21 mg, followed by 35 mg and then 70 mg, over a further optimized eight-week dose escalation period.
Amgen also expects to initiate Phase 3 clinical outcomes studies for atherosclerotic cardiovascular disease and heart failure and a Phase 3 study for obstructive sleep apnea in 2025.
William Blair writes, “Treatment policy estimand weight loss data clearly disappointing (12.3% to 16.2% weight loss range), but we believe reducing discontinuations with additional titration and longer time point (72 weeks) could still put Phase 3 results near 20%.”
Analyst Matt Phipps says the Phase 2 results show lower doses can still lead to meaningful weight loss. The 280 mg dose led to the quickest results. However, he questions if higher doses might be better for less frequent dosing, such as every two or three months.
The analyst questions whether expanding the dosing interval beyond every four weeks (Q4W) would result in increased GI adverse events on subsequent doses or a loss of tolerance.
Price Action: AMGN stock is up 1.96% at $277.78 at the last check on Tuesday.
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Photo: Courtesy of Amegen