Amgen, Inc. AMGN shares rallied over 14% in Thursday’s after-hours trading after the biopharma reported a double beat and offered an update on its obesity drug pipeline.
What Happened: Amgen said on the call that it was pulling the plug on AMG 786, an oral Phase 1 candidate for obesity. “We will not pursue further development. Instead, in obesity, we’re differentially investing in MariTide and a number of preclinical assets,” said Amgen’s EVP and Chief Scientific Officer Jay Bradner.
The rationale offered was prioritization. “Across the portfolio, we are presently prioritizing differentiated medicines, those that stand to provide the greatest benefit for patients,” he said.
MariTide, formerly AMG 133, is an injectable form of drug targeting two gut hormones — gastric inhibitory polypeptide receptor, or GIP, and glucagon-like peptide 1, or GLP-1, which is being investigated in a Phase 2 trial for the treatment of obesity.
In this introductory remarks on the earnings call, Robert Bradway, CEO of Amgen, said interim Phase 2 analysis of data from the study was complete, and that the results were very encouraging. “Following the interim analysis, I would say we’re confident in MariTide’s differentiated profile and believe it will address important unmet medical needs,” he said.
Giving more color, Bradner said all arms in the study remained active and patient dropout hasn’t been an issue. He also said the top-line 52-week data from the 11-arm Phase 2 study is on track for a readout in late-2024.
“We’re seeing a differentiated profile of MariTide and are confident that it will address important unmet medical needs, obesity, obesity-related conditions, and diabetes, the executive said.
The company is looking ahead to complete the Phase-2 study and work along with the Food and Drug Administration to expeditiously move it to the Phase-3 stage. It is also planning to initiate an additional dedicated Phase 2 study, investigating MariTide for the treatment of diabetes in patients with and without obesity.
Bradner also said the company plans to deliver MariTide in a “convenient, handheld, patient-friendly auto-injector device with a monthly or even less frequent single-injection administration, assuming eventual approval.”
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Why It’s Important: The huge popularity of obesity drug follows the weight-loss revolution that is taking hold. Novo Nordisk’s diabetes drug Ozempic was approved for obesity under the brand name Wegovy in 2021. These class of drugs mimic the action of the GLP-1 hormone to regulate blood sugar, slow digestion and suppress hunger.
Eli Lilly’s Zepbound is the second weight-loss drug of this category approved for use. It contains the same active ingredient as Lilly’s Type 2 diabetes drug Mounjaro.
Both companies benefited from the strong uptake of their respective weight-loss drugs, prompting others to dip their toes into the segment.
Not all have tasted the same degree of success. Pfizer, for one, announced the ditching of the development of danuglipron, its oral weight-loss drug candidate, which was then in Phase 3 development.
MariTide, like, Lilly’s Zepbound and Novo Nordisk’s Wegovy, targets the receptors for GLP-1 hormone. While Zepbound increases the activity of GLP-1 as well as GIP receptors, MariTide increases GLP-1 receptor activity, while toning down on the receptor for GIP, Fierce Pharma reported.
The stakes are high, with the weight-loss drug market estimated at a mouth-watering $100 billion, Reuters reported.
Amgen shares rose 14.59% to $319, according to Benzinga Pro data. If the after-hours gains hold good, the stock is on track to open at the highest level since early February.
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