Maridebart Cafraglutide

Pictured: Amgen's office in Florida/iStock, JHVEPhoto Amgen released its first-quarter 2024 earnings report on Thursday, touting a 22% increase in total revenues as well as positive mid-stage results for its next-generation obesity candidate MariTide. The pharma did not reveal specific data for MariTide but CSO James Bradner said in an investor call on Thursday that the company was “confident” in the candidate’s differentiated profile, noting that it has the potential to “address important unmet medical needs, obesity, obesity-related conditions and diabetes.” Amgen is now working to wrap up the ongoing Phase II study, after which it plans to engage regulators “to move rapidly to the broad Phase III program,” Bradner said. The company is also gearing up for an additional dedicated Phase II trial later this year, testing MariTide for the treatment of diabetes in patients with and without obesity. However, Bradner explained that the additional mid-stage study “is not a gating step” for the Phase III program but is instead “the next step towards a diabetes indication for MariTide.” MariTide is an injectable bispecific molecule that can simultaneously inhibit the GIP receptor and activate the GLP-1 receptor. In February 2024, Amgen published Phase I data for MariTide showing that the investigational treatment could cut body weight by 14.5% at 85 days in obese participants without diabetes. These findings also suggest that MariTide could have longer-lasting effects than currently available obesity treatments. Meanwhile, as Amgen accelerates the development of one obesity candidate, it has also terminated its work on an early-stage obesity pill. During Thursday’s investor call, Bradner revealed that the pharma “will not pursue further development” of its early-stage small molecule drug candidate AMG 786. Amgen did not provide much detail regarding AMG 786, announcing only in its earnings announcement that a Phase I study for the asset “is complete.” Responding to a question from an analyst, Bradner said that MariTide “really raises the bar for Amgen obesity medicines” and that AMG 786 “just did not meet that bar in our assessment.” In the first quarter of 2024, Amgen reported $7.4 billion in total revenues, up 22% from the same period the prior year. However, the pharma’s diluted earnings-per-share slid slightly to $3.96 in Q1, down from $3.98 during the same period in 2023. Amgen’s top-performing asset in Q1 was the osteoporosis treatment Prolia (denosumab), which brought in nearly $1 billion, followed by Enbrel (etanercept), indicated for rheumatoid arthritis and plaque psoriasis, which secured $567 million. The company’s revenue growth was also fueled by Repatha (evolocumab) and Evenity (romosozumab-aqqg), which saw a 33% and 35% year-over-year increase in sales, respectively. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Dive Brief:Amgen shares soared by double digits Friday following its announcement an obesity drug its developing has shown enough promise to warrant advancing into late-stage testing.On an earnings call with analysts Thursday, CEO Robert Bradway said the company is confident in the drugs differentiated profile following an internal review of interim Phase 2 study results. Full data are expected by the end of the year and should support a subsequent move into Phase 3 trials, executives said.Yet Amgens drug is likely at least two years away from regulators desks, by which time Eli Lilly and Novo Nordisk may already have successors to their weight loss medicines Wegovy and Zepbound. It will take even more time to accumulate data to prove the drug can protect heart health, a key claim for convincing commercial and federal insurers to reimburse for treatment.Dive Insight:Amgens market capitalization swelled $20 billion following the announcement, a surge that reflects intense investor interest in emerging weight loss medicines.The biotechs lead drug, called maridebart cafraglutide or MariTide, acts on the same targets that Zepbound does, hormones called GLP-1 and GIP. But unlike Zepbound, MariTide blocks, rather than stimulates, GIP. Amgen also aims to show the drug can effectively cut weight with a once-monthly shot, instead of the weekly injections required for Zepbound and Wegovy.But theres little known publicly about the drugs potential.We've just seen really a small amount of data. So probably anything is possible and, like you, we will be interested to see their results, said Lillys top scientist, Daniel Skovronsky said on an earnings call earlier this week. We've placed our bets, and we like the data we got.Amgen, though, is now expressing enough confidence to warrant making a substantial investment in late-stage studies. During the conference call Thursday, executives didnt disclose specific data, but said all 11 study arms of the two-stage, placebo-controlled trial remain active. They also said there has not been an issue with patients stopping treatment due to side effects.The trial enrolled people with obesity or who are overweight and have another health condition. Diabetics were tested separately to better understand the drugs effects on people with the disease.Amgen executives have viewed the interim data, but trial investigators and participants are still blinded to preserve the trials scientific integrity, they said. The company is stopping work on another obesity drug prospect, AMG 786, as early data showed it doesnt have the same potential as MariTide.Should MariTide advance into Phase 3, it would likely need to be tested in a trial lasting more than a year, just as Wegovy and Zepbound were. To be competitive, Amgen also will need run the type of large, multiyear trial that can prove whether MariTide protects heart health.In the meantime, Novo and Lilly will be able to further entrench their drugs on the market. Already, theyve made significant inroads, with Wegovy recording $1.3 billion in sales in the first quarter and Zepbound $517 million. Both are also seeing prescription numbers climb and are investing heavily in manufacturing.In addition, both Novo and Lilly are nearing Phase 3 readouts for successor drugs, which, if positive, could raise the bar for would-be competitors.I think they will remain the dominant players not only given existing leadership position but also because of the rebate wall they have constructed, Umer Raffat, an analyst with Evercore ISI, wrote in a note to clients. '