Pfizer on Thursday he said he would proceeded with a daily version of its weight-loss pill, danuglipron, after seeing “encouraging” data in an ongoing early-stage study.
The company evaluated several once-daily formulations of the drug and identified one with “the most favorable profile” in terms of safety and how the body reacts to the drug.
Pfizer said it plans to conduct more early-stage trials in the second half of the year to identify the ideal dose of the drug, with results expected in the first quarter of next year, a spokesperson told CNBC. The company said these tests “will inform registration-enabling studies,” which are used in applications for regulatory approval.
Danuglipron “has demonstrated good efficacy in a twice-daily formulation, and we believe that a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space,” said Pfizer’s outgoing Chief Scientific Officer Dr. Mikael Dolsten. release. Specifically, the company observed no hepatic safety issues in patients receiving once-daily formulations of the drug.
Pfizer is one of several drugmakers fighting to win a piece of the market for a wildly popular class of weight-loss and diabetes drugs called GLP-1 agonists. Some analysts expect the industry to be worth it about $100 billion vs the end of the decade.
But Pfizer has so far struggled to break into the market.
The pharmaceutical giant in December discontinued a twice-daily version of danuglipron after patients had trouble tolerating the drug in a mid-stage study. At the time, Pfizer said early study data on the once-daily version would be “update a path forward.”
But investors have been pessimistic about the company’s potential in the GLP-1 space since it withdrew a different once-daily pill in June 2023 because of elevated liver enzymes in patients who received the treatment. Those were among a series of setbacks Pfizer faced last year, in addition to the rapid decline in its Covid business, which hit its stock.
However, Pfizer has others experimental obesity drugs in the early stages of development. The company has not disclosed how these treatments will work.
“Obesity is a key therapeutic area for Pfizer, and the company has a strong pipeline of three clinical and several preclinical candidates,” Dolsten said in the release.
Pfizer also believes that GLP-1s are “scratching the surface of what we’re going to see in obesity,” CEO Albert Bourla said during a conference in June.
Pfizer’s danuglipron is a GLP-1 that promotes weight loss in the same way as Novo Nordisk’s Wegovy injection and Ozempic diabetes treatment. The drugs mimic a single hormone produced in the gut called GLP-1, which signals the brain when a person is full.
Injections from Novo Nordisk and Eli Lilly have skyrocketed in demand over the last year despite their high prices and limited insurance coverage.
The pair – along with Pfizer and other drugmakers – are racing to develop oral versions that are more convenient for patients and easier to prepare, which could help ease supply shortages in the US.
Pfizer has previously said it could acquire or partner with a smaller obesity drug company.
Burla told reporters at a conference in January that it was unlikely that Pfizer would buy an obesity treatment at a later stage of development, especially as the company focuses on cutting costs.
However, he said Pfizer was looking at potential licensing deals or early-stage weight loss drugs.
Pfizer’s update on danuglipron comes days after the company said it was looking for a successor to Dolsten, who will resign after more than 15 years in pharmacopoeia. Dolsten played a critical role in the development of Pfizer’s Covid vaccine.
