Amgen is positioning its investigational therapy, MariTide (maridebart cafraglutide), as a potential game-changer in the obesity market, emphasizing its once-monthly dosing and robust manufacturing capabilities. CEO Robert Bradway, speaking at the JP Morgan Healthcare Conference 2025, highlighted the potential of MariTide as a long-acting treatment option for obesity, overweight, and type 2 diabetes (T2D).
MariTide's Clinical Performance
Phase II trial data for MariTide, a bispecific glucagon-like peptide 1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist, demonstrated significant weight loss in patients. In individuals without T2D, MariTide achieved up to 20% average weight loss at week 52, without a weight loss plateau. Patients with obesity or overweight and T2D experienced up to 17% average weight loss and a reduction in average haemoglobin A1C (HbA1c) by up to 2.2 percentage points at week 52.
Addressing Bone Mineral Density Concerns
Concerns regarding bone mineral density (BMD) loss associated with MariTide were previously raised. However, Amgen has stated that they have not observed an association between MariTide administration and BMD changes, reiterating this in their Phase II data update.
Manufacturing Expansion
Recognizing the supply challenges faced by Novo Nordisk and Eli Lilly with their obesity therapies, Amgen is investing $1.02 billion to expand the manufacturing capability of its facility in Holly Springs, North Carolina. This expansion aims to ensure a reliable supply of MariTide upon potential approval.
Phase III Trials and Future Plans
Amgen plans to initiate Phase III trials for MariTide in the first and second halves of 2025. These trials will further evaluate the efficacy and safety of MariTide in a broader patient population.
Other Pipeline Developments
In addition to MariTide, Amgen is advancing other pipeline candidates, including:
- Olpasiren: A small interfering RNA (siRNA) therapy targeting lipoprotein(a) (Lp(a)) and low-density lipoprotein cholesterol (LDL-C) to reduce cardiovascular event risk. Currently in Phase III studies.
- Blinctyro (blinatumomab): A monoclonal antibody targeting the CD19 antigen on B cells, approved for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukaemia. It is being investigated in other therapeutic areas, with promising initial data in refractory rheumatoid arthritis and a Phase II study in systemic lupus erythematosus (SLE).
Amgen is also progressing with Phase III trials for biosimilars of Keytruda, Opdivo, and Ocrevus, building on the $10 billion in cumulative sales generated by its existing biosimilar portfolio.
