Amgen is trying to problem the duopoly of Novo Nordisk and Eli Lilly within the injectable weight problems drug market, and the corporate is now making ready for Part 3 testing of an injectable drug candidate that will introduce new competitors. Whereas executives aren't but sharing particular particulars of the scientific information supporting these plans, Amgen's drug candidate might have dosing and manufacturing benefits.

The replace for the drug, maridebart cafraglutide or MariTide (often called AMG 133 in earlier levels of improvement), got here with Amgen's first-quarter 2024 monetary outcomes report. CEO Robert Bradway mentioned the corporate doesn’t usually touch upon interim information . significantly for a Part 2 drug candidate, however would offer some data given the numerous curiosity in MariTide.

“We’re assured in MariTide's differentiated profile and imagine it can handle necessary unmet medical wants,” Bradway mentioned throughout a convention name Thursday.

The Part 3 program for MariTide will consider the drug in weight problems, obesity-related situations and kind 2 diabetes, Bradway mentioned. Amgen has additionally begun increasing its manufacturing capabilities to help each scientific and industrial provide of the drug.

The favored weight medicines Wegovy, from Novo Nordisk, and Zepbound, from Eli Lilly, are peptide medicine designed to activate the GLP-1 receptor, which ends up in sufferers feeling full so that they eat much less. Lilly's drug offers the extra mechanism for activating a second receptor, GIP. Each medicine are given as weekly injections.

MariTide leverages Amgen's expertise creating antibody medicine. The design of the molecule consists of an antibody conjugated to a polypeptide and offers a twin mechanism. It prompts the GLP-1 receptor just like the Novo Nordisk and Lilly merchandise. However in contrast to Lilly's treatment, MariTide blocks the GIP receptor. In section 1 testing, the drug led to dose-dependent weight reductions. Amgen reported preliminary information from this examine in late 2022. The complete outcomes have been printed in February within the journal Nature Metabolism.

MariTide's Part 2 trial is a placebo-controlled dose-ranging examine evaluating three doses in practically 600 overweight and chubby sufferers, together with sufferers with or with out kind 2 diabetes. The principle goal is to measure the change in physique weight after 52 weeks.

Whereas Amgen stays silent on preliminary efficacy particulars from the Part 2 trial, Amgen Government Vice President, Analysis and Growth and Chief Scientific Officer Jay Bradner mentioned MariTide may be dosed month-to-month through an auto-injector gadget, providing much less frequent dosing than the Novo Nordisk or Lilly medicine. This dosing schedule provides further advantages, William Blair analyst Matt Phipps wrote in a analysis observe Friday. Phipps mentioned he nonetheless expects MariTide to result in the identical unwanted side effects of nausea and vomiting which can be widespread with different GLP-1 agonists, however month-to-month or probably even quarterly dosing would nonetheless lead to considerably fewer sick days in comparison with medicine taken weekly. administered.

“We imagine this shall be particularly necessary for sufferers who’ve misplaced vital weight and are much less tolerant of persistent unwanted side effects however would nonetheless profit from upkeep remedy to forestall weight regain,” mentioned Phipps.

Much less frequent dosing would additionally take pleasure in lowering the manufacturing burden of manufacturing the drug and auto-injectors, Phipps added. The robust demand for brand new medicine towards metabolic illnesses has exceeded the flexibility of drug producers to provide their merchandise. Novo Nordisk and Lilly have invested billions of {dollars} in their very own manufacturing capabilities and purchased manufacturing belongings to extend manufacturing capability.

Amgen expects preliminary Part 2 information for MariTide to be introduced in late 2024. Within the meantime, one other Amgen drug is dropping out of the race to supply sufferers an oral weight problems drug. Bradner mentioned the corporate will not proceed improvement of the small molecule codenamed AMG 786, which has accomplished section 1 testing. Bradner supplied no further particulars, aside from to say that given the drug's profile, the corporate has chosen to focus its metabolic illness efforts on MariTide and a number of other different preclinical brokers. The corporate by no means disclosed the goal of AMG 786.

Photograph: Patrick T. Fallon/Bloomberg, through Getty Photographs