Amgen’s MariTide is steadily making its way toward the booming weight loss drug market, which is estimated to be worth about $200B by 2030. Last week, the biotech announced results of a Phase II, 52-week study of MariTide (maridebart cafraglutide, formerly AMG 133).
The study included overweight or obese people with and without type 2 diabetes. Those without diabetes saw a 20% average weight loss, those with diabetes saw about an average 17% weight loss. Also, the diabetics lowered their average hemoglobin A1C (HbA1c) by up to 2.2 percentage points at week 52. A weight loss plateau was not observed in either subjects with or without diabetes, suggesting the potential for further weight loss beyond 52 weeks in either group.
A key distinction, MariTide is expected to be delivered as a single dose in a convenient, handheld, patient-friendly, device with a monthly or less frequent single-injection administration.
MariTide also demonstrated robust and clinically meaningful improvements in cardiometabolic parameters, including blood pressure, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) across doses. There were no significant increases in free fatty acids and no association between MariTide and bone mineral density changes.
“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,” said Jay Bradner, MD, executive vice president of research and development and CSO at Amgen.
The most common adverse events (AEs) in the Phase II study were gastrointestinal related, including nausea, vomiting, and constipation. Nausea and vomiting were predominantly mild, transient, and primarily associated with the first dose. No additional safety signals were identified.
“These results provide us confidence to initiate MARITIME, a Phase III program across obesity and a number of related conditions, providing a unique potential new treatment option for patients,” Bradner said.
Obesity increases the risk of many other serious conditions, including type 2 diabetes, heart failure, kidney disease, sleep apnea, atherosclerotic cardiovascular disease, and metabolic dysfunction-associated steatohepatitis. The worldwide prevalence of obesity more than doubled between 1990 and 2022. In the United States, more than two in five adults (42.5%) are living with obesity. In 2022, 890 million adults (18 years and older) globally were living with obesity, and 2.5 billion adults were living with overweight.
Amgen also said it is advancing its obesity pipeline, which includes both oral and injectable approaches, composed of both incretin and non-incretin mechanisms. It’s been estimated that there will be about 60 new weight-loss drugs on the market over the next few years.
MariTide is a bispecific glucagon-like peptide 1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist being investigated for the treatment of obesity and type 2 diabetes mellitus. It is a pioneering antibody-peptide conjugate molecule with a long half-life and dual mechanism of action.
Preclinical studies have demonstrated that simultaneously activating GLP-1 and inhibiting GIP pathways had a stronger effect on weight loss than targeting either GLP-1 or GIP receptors alone. MariTide, may thus, have greater durability or reduce the likelihood of weight rebound after treatment stops.
