Amgen aims to challenge the Novo Nordisk and Eli Lilly duopoly in the market for injectable obesity medications, and the company is now preparing for Phase 3 testing of an injectable drug candidate that would introduce new competition. While executives are not yet sharing specific details of the clinical data that support these plans, Amgen’s drug candidate could have dosing and manufacturing advantages.
The update for the drug, maridebart cafraglutide or MariTide (known in earlier stages of development as AMG 133), came with Amgen’s report of financial results for the first quarter of 2024. CEO Robert Bradway said the company does not normally comment on interim data, particularly for a drug candidate in Phase 2, but would offer some information given the significant interest in MariTide.
“We are confident in MariTide’s differentiated profile and believe it will address important unmet medical needs,” Bradway said during a conference call Thursday.
The Phase 3 program for MariTide will evaluate the drug in obesity, obesity-related conditions, and type 2 diabetes, Bradway said. Amgen has also begun expanding its manufacturing capabilities to support both clinical and commercial supply of the drug.
The popular weight medications Wegovy from Novo Nordisk and Zepbound from Eli Lilly are peptide drugs engineered to activate the GLP-1 receptor, which has the effect of helping patients feel full so they eat less. Lilly’s drug offers the additional mechanism of activating a second receptor, GIP. Both drugs are administered as weekly injections.
MariTide leverages Amgen’s experience developing antibody drugs. The molecule’s design consists of an antibody conjugated to a polypeptide and it offers a dual mechanism. It activates the GLP-1 receptor like the Novo Nordisk and Lilly products. But unlike Lilly’s medication, MariTide blocks the GIP receptor. In Phase 1 testing, the drug led to dose-dependent weight reductions. Amgen reported preliminary data from this study in late 2022. Full results were published in February in the journal Nature Metabolism.
The Phase 2 test of MariTide is a placebo-controlled dose-ranging study evaluating three doses in nearly 600 patients who are obese and overweight, including patients with or without type 2 diabetes. The main goal is measuring the change in body weight after 52 weeks.
While Amgen is staying mum on efficacy details from the Phase 2 study, Amgen Executive Vice President, Research and Development, and Chief Scientific Officer Jay Bradner said MariTide could be dosed monthly via an autoinjector device, offering less frequent dosing than the Novo Nordisk or Lilly drugs. This dosing schedule offers additional advantages, William Blair analyst Matt Phipps wrote in a Friday research note. Phipps said he still expects MariTide will lead to the same nausea and vomiting side effects that are common with other GLP-1 agonists, but monthly or potentially even quarterly dosing would still result in meaningfully fewer total sick days compared to drugs that are administered weekly.
“We believe this will be particularly important for patients who have lost meaningful weight and are less tolerant of continued side effects, but would still benefit from maintenance therapy to prevent weight rebound,” Phipps said.
Less frequent dosing would also have the advantage of reducing the manufacturing burden of producing the drug and the autoinjectors, Phipps added. Strong demand for new metabolic disorder medications has outpaced drugmakers’ ability to supply their products. Novo Nordisk and Lilly have invested billions of dollars in their own manufacturing capabilities and acquired manufacturing assets to increase production capacity.
Amgen expects the preliminary Phase 2 data for MariTide will be announced in late 2024. In the meantime, a different Amgen drug is dropping out of the race to bring patients an oral obesity medication. Bradner said the company will no longer pursue development of the small molecule code-named AMG 786, which has completed Phase 1 testing. Bradner offered no additional details other than to say that given the drug’s profile, the company has chosen instead to focus its metabolic disease efforts on MariTide and several other preclinical assets. The company has never disclosed the target of AMG 786.
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