Amgen says MariTide demonstrated up to 20% average weight loss in Phase 2 study

Amgen (AMGN) announced full results from Part 1 of the Phase 2 study of MariTide, a long-acting, peptide-antibody conjugate subcutaneously administered monthly or less frequently. In addition to these data, complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation study evaluating lower starting doses of MariTide were presented as part of an expert-led Symposium at the 85th American Diabetes Association 85th Scientific Sessions and simultaneously published in The New England Journal of Medicine. In the Phase 2 study, MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes 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.1 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 of up to 2.2% in people living with obesity and T2D. Weight loss with MariTide was also accompanied by improvements across pre-specified cardiometabolic measures, including waist circumference, blood pressure, high-sensitivity C-reactive protein and select lipid parameters. “MariTide delivered strong efficacy, including sustained weight loss without a plateau in the 52-week Phase 2 study and meaningful improvements in cardiometabolic risk factors, representing a defining advance for the obesity field,” said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. “These results, alongside the Phase 1 Pharmacokinetics Low Dose Initiation data, have shaped our Phase 3 MARITIME program. MariTide’s monthly or less frequent dosing has the potential to improve adherence and long-term weight control, providing the opportunity to optimize health outcomes for people living with obesity, Type 2 diabetes and related conditions.” No new safety signals were identified in the Phase 2 study and tolerability was consistent with the GLP-1 class. The most frequently reported adverse events were gastrointestinal related, and most were mild to moderate. The study employed a rigorous daily patient reporting tool known as the MINVR to actively solicit the presence of select GI symptoms in addition to standard unsolicited AE reporting. Gastrointestinal events were predominantly limited to initial dosing and less frequent when dose escalation was used without compromising efficacy. Discontinuation rates of MariTide due to GI AEs in the dose escalation arms were lower than non-dose escalation arms.