Amgen readies Phase III for weight-loss drug, ups manufacturing
02 May 2024
Phase 1Phase 2Phase 3Clinical ResultFinancial Statement
Investor appetite for obesity treatments is nowhere near satiated, if Amgen’s after-hours surge is any indicator. After executives hinted at positive Phase II data for its experimental weight-loss drug AMG 133 – also known as maridebart cafraglutide (MariTide) – during a call to discuss the pharma’s quarterly earnings, Amgen saw its stock soar upwards of 14%.
If the move holds on Friday, the whispers of weight-loss data will have boosted Amgen’s market cap by nearly $20 billion.
“The interim Phase II analysis is complete, and we are very encouraged with the results we’ve seen thus far,” chief executive Bob Bradway commented on the call. “I would say we're confident in MariTide’s differentiated profile and believe that it will address important unmet medical needs.”
While specific data were not disclosed – topline results won’t be revealed until late 2024 – Bradway said that “the actions we’re taking speak for themselves,” referencing a Phase III programme for MariTide announced Thursday, as well as a commitment to manufacturing.
The company also posted an estimate-beating quarter, coming out ahead of both sales and profit expectations.
Phase III on the horizon
Based on the interim data, Amgen is planning to move “rapidly” to a broad Phase III programme that will test MariTide in patients with obesity, diabetes, and “obesity-related conditions.” While management did not elaborate on the third patient group, it could be part of a push to score a cardiovascular benefit approval, akin to what Novo Nordisk’s Wegovy (semaglutide) earned earlier this year – an indication that will help the GLP-1 reach Medicare patients.
According to Bradner, MariTide will be delivered with a “convenient, handheld, patient- friendly autoinjector device, with monthly or even less frequent single injection administration.”
Manufacturing edge?
Amgen also disclosed Thursday that it has begun expanding its manufacturing capacity for MariTide “with both clinical and commercial capacity in mind.”
While “it's not lost on us that the competitors who are in the market now have found it difficult to maintain supply” of their weight-loss drugs, Bradway expressed confidence in Amgen’s ability to live up to the challenge of manufacturing MariTide – particularly because it’s a slightly different modality than existing GLP-1s.
“We’ve established ourselves firmly as a world leader in biotherapeutic manufacturing, and as you know, this is a therapy based on an antibody backbone, so it’s right down the middle of the fairway for us,” he explained. “Our capital expenditure guidance for the year embraces the activity that we have underway to make ourselves ready for the clinical and commercial challenge that we see.”
Turning GIP sentiments
The company also seems to have put most of its obesity eggs in the MariTide basket, announcing on the call that it has scrapped small molecule AMG 786 following a Phase I trial. “Given the profile we've seen with AMG 786, we will not pursue further development,” Bradner said. “Instead, in obesity, we’re differentially investing in Maritide and a number of preclinical assets,” which include both oral and injectable programmes.
Investor enthusiasm towards MariTide has undergone a major turnaround since the lukewarm reception of Phase I data, shared in February. The bispecific’s mechanism of action has been a lingering point of uncertainty as it inhibits the GIP hormone – while the widely successful Zepbound activates GIP, along with GLP-1.
While MariTide achieved dose-dependent weight loss in the Phase I trial, including an average of 14.5% at the highest (420 mg) of three dose levels, four of the eight patients enrolled in that high-dose cohort withdrew from the study before receiving a second dose. Additionally, no clinically meaningful changes in blood pressure were reported, nor was there a statistically significant reduction in lipids. For more analysis, see Spotlight On: Amgen’s early AMG 133 data score another point for GIP agonism in obesity.
Bradner emphasised on Thursday’s call that the Phase II trial “hasn’t had an issue with patient drop-out to-date.”
Climbing sales
The pharma reported revenues of $7.45 billion for the three-month period, up 22% from last year and edging past analyst estimates of $7.44 billion.
Among those driving the revenue boost were high cholesterol treatment Repatha (+33% to $517 million), osteoporosis drug Evenity (+35% to $342 million), and B-cell precursor acute lymphoblastic leukaemia therapy Blincyto (+26% to $244 million).
Amgen now expects full-year revenues between $32.5 billion and $33.8 billion, bumping up the bottom end of its earlier forecast by $100 million. It also narrowed its adjusted earnings in the range of $19 to $20.20 per share from between $18.90 and $20.30 per share previously.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.