Amgen’s Weight Loss Drug MariTide Enters Late-Stage Trials
Amgen, the biotechnology giant based in Thousand Oaks, California, recently announced the commencement of two crucial late-stage trials for their groundbreaking weight loss injection, MariTide. This development marks a significant milestone in the company’s efforts to penetrate the rapidly expanding obesity drug market. Dr. Jay Bradner, Amgen’s executive vice president of research and development, expressed his enthusiasm for the progress of the MARITIME program during a recent TD Cowen conference, where he provided insights into the drug’s phase three development program.
MariTide represents a monthly injection that has garnered attention from investors as a potential competitor to existing weight loss drugs offered by Novo Nordisk and Eli Lilly, which are administered on a weekly basis. Classified as a GLP-1 agonist, MariTide functions by mimicking gut hormones to suppress appetite and regulate blood sugar levels. According to a survey conducted by the health policy organization KFF, approximately 6% of U.S. adults, totaling more than 15 million individuals, were prescribed GLP-1s as of May. Analysts predict that the market for GLP-1s could exceed $150 billion annually by the early 2030s, underscoring the immense potential of this drug class.
Exploring the Late-Stage Trials
The two pivotal late-stage trials initiated by Amgen will involve a comprehensive examination of MariTide’s efficacy in different cohorts. The first trial aims to evaluate the drug’s impact on approximately 3,500 individuals with obesity or overweight but without Type 2 diabetes. The second trial focuses on 999 patients who are both obese or overweight and have Type 2 diabetes. The primary objective of both studies is to assess the percentage of weight loss achieved at the 72-week mark. To achieve this goal, Amgen plans to investigate three distinct doses of MariTide, employing a dose escalation strategy to optimize patient outcomes. While the company has not disclosed specific dosing regimens for the trials, the utilization of varied doses underscores their commitment to identifying the most effective treatment approach.
In a phase two trial conducted by Amgen, MariTide demonstrated promising results, with patients experiencing an average weight loss of up to 20% after one year for those with obesity and no weight loss plateau observed. Similarly, individuals with obesity and Type 2 diabetes achieved a weight reduction of up to 17% without encountering a plateau effect. Notably, these outcomes, while encouraging, fell slightly below the ambitious expectations set by the investment community. Amgen has scheduled the release of additional data on MariTide later this year, with the full phase two trial results slated for presentation at the American Diabetes Association conference in June. Furthermore, the company is actively pursuing an extension of the trial to further evaluate patient outcomes, with results expected in the latter half of the year.
The Unique Mechanism of MariTide
What sets MariTide apart from its competitors is its innovative approach to weight loss intervention. As a peptide antibody conjugate, the drug combines the properties of a monoclonal antibody with two peptides. These peptides activate receptors associated with GLP-1, a gut hormone that plays a key role in appetite regulation and blood sugar control. Additionally, the antibody component blocks receptors linked to another hormone called GIP, enhancing the drug’s efficacy in promoting weight loss. This mechanism differs from existing medications such as Eli Lilly’s Zepbound, which activates both GIP and GLP-1, and Novo Nordisk’s Wegovy, which selectively targets GLP-1 without affecting GIP pathways. By leveraging this novel peptide antibody conjugate technology, Amgen aims to offer a more targeted and effective solution for individuals struggling with obesity and related metabolic conditions.
As Amgen embarks on this transformative journey with MariTide, the company remains committed to advancing the field of obesity therapeutics and addressing the unmet needs of patients worldwide. With the promise of improved outcomes and enhanced treatment options on the horizon, the ongoing trials of MariTide hold the potential to redefine the landscape of weight loss interventions and empower individuals to achieve lasting health and well-being.
