Amgen says experimental obesity drug has promising shelf life

LOS ANGELES, Dec 3 (Reuters) – Amgen Inc’s ( AMGN.O ) experimental obesity drug demonstrated promising durability trends in an early trial, paving the way for a larger mid-phase trial early next year, company officials said ahead of a data presentation on Saturday.

The small phase I study found that patients maintained their weight loss for 70 days after receiving the highest tested dose of the injected drug, currently known as AMG1[ads1]33.

Amgen shares have risen about 5% since the company said on Nov. 7 that 12 weeks of trial treatment with the highest monthly dose of AMG133 resulted in average weight loss of 14.5%.

By 150 days after the last dose, sustained weight loss had fallen to 11.2% below the initial weight at the start of the trial, according to findings described at a meeting of the World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease in Los Angeles.

Patients treated with AMG133 had side effects including nausea and vomiting, but most cases were mild and resolved within a few days of the first dose, Amgen said.

The US Centers for Disease Control and Prevention estimates that more than 40% of the US population is obese, costing nearly $173 billion annually. It is a primary cause of type 2 diabetes and has been linked to heart disease, certain cancers and other health complications such as more severe COVID-19.

The weight loss field has received renewed medical and investor attention in recent months after diabetes drugs from Eli Lilly and Co and Novo Nordisk ( NOVOb.CO ), known as semaglutide and tirzepatid, have been shown to help obese patients lose weight.

Both of these medications, which must be injected every two weeks, are designed to activate GLP-1, a hormone that triggers the feeling of fullness in the body after eating.

Amgen’s AMG133 also targets GLP-1, but has a dual mechanism that aims to simultaneously block the activity of a gene known as GIP.

The drug was developed from work at Amgen to identify genetic signals associated with lower fat mass and body weight, as well as healthy metabolic profiles, explained Saptarsi Haldar, head of cardiovascular metabolic discovery at Amgen.

“Genetics clearly showed in several large populations that reduced activity genetically of the GIP receptor gene was associated with lower BMI (body mass index),” he said.

The California-based biotech said it plans to launch a larger mid-phase study of AMG133 early next year, which will enroll a wider range of patients, including those with additional health conditions such as diabetes.

JP Morgan analyst Chris Schott said earlier this month that if all goes well, a Phase III study of AMG133 could begin in 2024, with a launch expected in 2026 or 2027, if approved.

Reporting by Deena Beasley Editing by Bill Berkrot

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