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Amgen (AMGN - Free Report) announced the much-awaited 52-week top-line data from a phase II study on MariTide, its GLP-1 therapy being developed for obesity and related conditions.
The data showed that MariTide led to sustainable weight loss, robust and clinically meaningful improvements in cardiometabolic parameters and a strong reduction of average blood sugar levels.
AMGN’s MariTide Study Data in Detail
The data from the double-blind dose-ranging study showed that in people who were obese or overweight but without type II diabetes, MariTide resulted in up to approximately 20% average weight loss over 52 weeks without reaching a weight loss plateau. In patients with type II diabetes who were obese or overweight, the weight loss reduction was approximately 17% at 52 weeks, with concurrent hemoglobin A1C (HbA1c) reduction by up to 2.2 percentage points. The weight loss in this patient group was also without a plateau, which means there is potential for further weight loss beyond 52 weeks.
MariTide also demonstrated other cardiometabolic benefits like sustained improvements in blood pressure, triglycerides and inflammation markers like high-sensitivity C-reactive protein (hs-CRP). The candidate also did not cause any significant increases in free fatty acids.
As regards safety and tolerability, the most common adverse events were mild, transient gastrointestinal issues, primarily nausea and vomiting, often associated with the first dose. The discontinuation rates due to adverse events were approximately 11%.
MariTide also did not result in any significant changes in bone mineral density (“BMD”). Earlier this month, some analysts at a global financial services firm claimed that a review of phase I data on MariTide showed that the candidate led to a drop in BMD. Reduced BMD can increase the risk of fractures. The concerns resulted in a sharp decline in the stock price though the company later dismissed the concerns.
Part 2 of the phase II study is now ongoing and is evaluating weight loss beyond 52 weeks, maintenance with lower or less frequent dosing and the durability of weight loss post-discontinuation of MariTide.
Why Did AMGN Stock Decline Despite the Strong Data?
Despite the encouraging data, Amgen’s stock declined almost 5% on Tuesday probably as the weight loss reduction was at the lower end of investor expectations of 20-25%. The 20% reduction was quite similar to that achieved by currently approved GLP-1 drugs for obesity, Eli Lilly’s (LLY - Free Report) Zepbound and Novo Nordisk’s (NVO - Free Report) Wegovy in clinical studies. Some analysts also felt the rate of discontinuations was higher than that seen with studies on Zepbound and Wegovy.
Amgen’s stock has declined 2.8% this year compared with a decrease of 7.9% for the industry.
Image Source: Zacks Investment Research
Amgen’s Obesity Pipeline is Progressing
Based on the encouraging data from the phase II study, Amgen expects to launch the phase III MARITIME study on MariTide across obesity, obesity-related conditions and type-II diabetes. Amgen began a phase II study on the candidate in type II diabetes in the third quarter.
Amgen has some preclinical obesity candidates in its pipeline, including oral and injectable approaches comprising both incretin and non-incretin mechanisms. Amgen began a phase I study on one of these candidates, AMG 513, for obesity in the third quarter.
LLY & NVO — Key Players in the Diabetes and Obesity Market
MariTide is a closely watched drug in the obesity market. The GLP-1 segment of the diabetes and obesity market is gaining significant popularity. Both Lilly’s Zepbound and NVO’s Wegovy are witnessing significant demand.
Amgen is developing MariTide as a single dose in a convenient autoinjector device with a monthly and maybe less frequent dosing, a key feature that differentiates it from Lilly’s Zepbound and Novo Nordisk’s Wegovy, which are weekly injections.
Another small biotech Viking Therapeutics (VKTX - Free Report) is making rapid progress with the development of VK2735, a GLP-1 and GIP receptor agonist, which is being developed as an oral and a subcutaneous formulation for treating obesity.
Image: Bigstock
AMGN Stock Down Despite Strong Data From Obesity Drug Study
Key Takeaways
Amgen (AMGN - Free Report) announced the much-awaited 52-week top-line data from a phase II study on MariTide, its GLP-1 therapy being developed for obesity and related conditions.
The data showed that MariTide led to sustainable weight loss, robust and clinically meaningful improvements in cardiometabolic parameters and a strong reduction of average blood sugar levels.
AMGN’s MariTide Study Data in Detail
The data from the double-blind dose-ranging study showed that in people who were obese or overweight but without type II diabetes, MariTide resulted in up to approximately 20% average weight loss over 52 weeks without reaching a weight loss plateau. In patients with type II diabetes who were obese or overweight, the weight loss reduction was approximately 17% at 52 weeks, with concurrent hemoglobin A1C (HbA1c) reduction by up to 2.2 percentage points. The weight loss in this patient group was also without a plateau, which means there is potential for further weight loss beyond 52 weeks.
MariTide also demonstrated other cardiometabolic benefits like sustained improvements in blood pressure, triglycerides and inflammation markers like high-sensitivity C-reactive protein (hs-CRP). The candidate also did not cause any significant increases in free fatty acids.
As regards safety and tolerability, the most common adverse events were mild, transient gastrointestinal issues, primarily nausea and vomiting, often associated with the first dose. The discontinuation rates due to adverse events were approximately 11%.
MariTide also did not result in any significant changes in bone mineral density (“BMD”). Earlier this month, some analysts at a global financial services firm claimed that a review of phase I data on MariTide showed that the candidate led to a drop in BMD. Reduced BMD can increase the risk of fractures. The concerns resulted in a sharp decline in the stock price though the company later dismissed the concerns.
Part 2 of the phase II study is now ongoing and is evaluating weight loss beyond 52 weeks, maintenance with lower or less frequent dosing and the durability of weight loss post-discontinuation of MariTide.
Why Did AMGN Stock Decline Despite the Strong Data?
Despite the encouraging data, Amgen’s stock declined almost 5% on Tuesday probably as the weight loss reduction was at the lower end of investor expectations of 20-25%. The 20% reduction was quite similar to that achieved by currently approved GLP-1 drugs for obesity, Eli Lilly’s (LLY - Free Report) Zepbound and Novo Nordisk’s (NVO - Free Report) Wegovy in clinical studies. Some analysts also felt the rate of discontinuations was higher than that seen with studies on Zepbound and Wegovy.
Amgen’s stock has declined 2.8% this year compared with a decrease of 7.9% for the industry.
Image Source: Zacks Investment Research
Amgen’s Obesity Pipeline is Progressing
Based on the encouraging data from the phase II study, Amgen expects to launch the phase III MARITIME study on MariTide across obesity, obesity-related conditions and type-II diabetes. Amgen began a phase II study on the candidate in type II diabetes in the third quarter.
Amgen has some preclinical obesity candidates in its pipeline, including oral and injectable approaches comprising both incretin and non-incretin mechanisms. Amgen began a phase I study on one of these candidates, AMG 513, for obesity in the third quarter.
LLY & NVO — Key Players in the Diabetes and Obesity Market
MariTide is a closely watched drug in the obesity market. The GLP-1 segment of the diabetes and obesity market is gaining significant popularity. Both Lilly’s Zepbound and NVO’s Wegovy are witnessing significant demand.
Amgen is developing MariTide as a single dose in a convenient autoinjector device with a monthly and maybe less frequent dosing, a key feature that differentiates it from Lilly’s Zepbound and Novo Nordisk’s Wegovy, which are weekly injections.
Another small biotech Viking Therapeutics (VKTX - Free Report) is making rapid progress with the development of VK2735, a GLP-1 and GIP receptor agonist, which is being developed as an oral and a subcutaneous formulation for treating obesity.
AMGN’s Zacks Rank
Amgen has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Amgen Inc. Price and Consensus
Amgen Inc. price-consensus-chart | Amgen Inc. Quote