'This field is in its infancy': Amgen noncommittal on oral obesity med until phase 1 data arrive

Amgen is, for now, staying the course with its two-pronged obesity development plan as the marketplace for arguably the most hyped class of drugs in decades continues to form. But executives were noncommittal about future development of an oral option, saying the plan will be based on the quality of a phase 1 readout in 2024. 

“There's a lot of work to do,” said David Reese, M.D., Amgen’s head of R&D, on Tuesday’s earnings call. “And as I've indicated, our intent here is to play the long game.” 

His comments followed an investor question about whether AMG-786 is a molecule that Amgen actually has conviction in and when the company expects to nominate another candidate. The asset is an oral option aimed at an undisclosed target currently in a phase 1 trial for obesity. 

Reese said investors should view AMG-786 as a phase 1 asset with a novel mechanism of action, and nothing more or less. Amgen expects the ongoing trial to read out in the first half of 2024, but wouldn’t commit to future investment just yet, saying that it’s a “high bar in this field.”

He declined to provide further guidance on when additional molecules could be named, saying only that they are molecules sourced from deCODE Genetics, an Icelandic drug discovery partner bought by Amgen in 2012. 

“If you step back, you know, this field is in its infancy,” said Reese. “We are just beginning to understand the complex metabolic derangements that occur with obesity and there are clearly different forms of obesity.”

Amgen's current obesity approach has been spearheaded by AMG-133, a multi-specific GIPR inhibitor and GLP-1 receptor agonist that just completed enrollment in a phase 2 trial with top-line data expected in 2024. Murdo Gordon, executive vice president of global commercial operations, believes that a dual-faceted approach will be a differentiator with respect to the durability of weight loss and reducing related disorders of obesity. 

“Our hope is to bring about real improvement in outcomes with a highly efficacious and highly convenient product like 133,” he said. 

Amgen is behind many of its peers when it comes to the obesity field. Novo Nordisk is the market leader, with semaglutide already marketed for obesity as Wegovy. Eli Lilly is soon to follow with Mounjaro, which is approved for diabetes but used off-label for weight loss. 

An oral option could turn the emerging drug class on its head, as existing options have to be injected on a weekly basis. But so far, moving to orals has not been easy, with Pfizer abandoning an early-stage project earlier this year on concerns of liver toxicity