Amgen's investigational drug, MariTide (maridebart cafraglutide), has shown promising results in a Phase 2 clinical trial for obesity and overweight management. The study, involving 592 adults, demonstrated significant weight loss, particularly in individuals without type 2 diabetes, paving the way for Phase 3 trials. However, the drug faces stiff competition and concerns over side effects.
Phase 2 Trial Results
The Phase 2 trial data revealed that participants without type 2 diabetes experienced an average weight loss of approximately 20% over 52 weeks. Notably, the study indicated that weight loss did not plateau, suggesting potential for continued reduction with longer treatment. For participants with type 2 diabetes, MariTide led to an average weight loss of about 17% and a reduction in hemoglobin A1C (HbA1c) levels by up to 2.2 percentage points.
Jay Bradner, MD, Executive Vice President of Research and Development and Chief Scientific Officer at Amgen, stated, "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."
Dosing and Administration
MariTide is administered subcutaneously, with the Phase 2 trial evaluating monthly or less frequent dosing schedules. This less frequent administration could be a key differentiator in the competitive obesity treatment market, potentially offering greater convenience for patients compared to weekly injections required by drugs like Novo Nordisk's Wegovy and Eli Lilly's Zepbound.
Safety and Tolerability
The most common adverse events reported in the Phase 2 study were gastrointestinal-related, including nausea, vomiting, and constipation. Amgen noted that these side effects were generally mild and transient, primarily associated with the first dose. Approximately 11% of patients in the dose escalation arms discontinued the trial due to adverse events, with less than 8% discontinuing due to gastrointestinal issues.
Competitive Landscape
Despite the positive results, Amgen's stock experienced a decline following the data release, reflecting concerns among investors and analysts. Some analysts had anticipated higher weight loss percentages, with expectations ranging from 23% to 25%. The market is currently dominated by Novo Nordisk's Wegovy and Eli Lilly's Zepbound, both of which have demonstrated significant efficacy in weight loss and are developing next-generation drugs.
Future Development
Amgen is moving forward with a Phase 3 clinical development program, MARITIME, to further evaluate MariTide in obesity and related conditions. This program will assess the drug's efficacy and safety in a broader patient population and explore its potential impact on cardiometabolic parameters and other obesity-related complications.
Obesity: A Growing Global Concern
Obesity is a significant global health issue, with the worldwide prevalence more than doubling between 1990 and 2022. In the United States, over 42% of adults are affected by obesity, increasing their risk of type 2 diabetes, heart disease, and other serious conditions. The development of new and effective treatments like MariTide is crucial to addressing this growing health crisis.
