Following strong Phase II data, Amgen is going all in on its next-generation obesity treatment MariTide, with plans to run a Phase III trial and a separate mid-stage study for diabetes.
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.
