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Pfizer on Thursday said it will move forward with a once-daily version of its weight-loss pill, danuglipron, after seeing “encouraging” data in an ongoing early-stage study.
The company evaluated several formulations of the once-daily 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 that evidence will “inform registration-enabling studies,” which are used in applications for regulatory approval.
Results are expected in the first quarter of next year, a spokesperson told CNBC.
Danuglipron “has shown 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 outgoing Pfizer chief scientific officer Dr. Mikael Dolsten in a release. Notably, the company did not observe any liver safety issues in patients taking once-daily formulations of the drug.
Pfizer is one of several drugmakers vying for market share for a very popular class of weight-loss and diabetes drugs called GLP-1 agonists. Some analysts expect the industry to be worth about $100 billion by 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 problems tolerating the drug in a mid-stage study. At the time, Pfizer said early study data on the once-daily version would “inform a way forward.”
But investors have been pessimistic about the company’s potential in the GLP-1 space since it scrapped a different once-daily pill in June 2023 because of elevated liver enzymes in patients who received the treatment. These were among a string of setbacks Pfizer faced last year, on top of the rapid decline in its Covid business, which hit its stock.
However, Pfizer has other experimental obesity drugs in early 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-1 is only “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 grown in demand over the past year, despite high prices and limited insurance coverage.
The pair – along with Pfizer and other drugmakers – have raced to develop oral versions that are more convenient for patients to take and easier to manufacture, which could help ease the shortage of supply in the US.
Pfizer has previously said it may buy or partner with a smaller obesity drug maker.
Bourla told reporters at a conference in January that it was unlikely the company would buy an obesity treatment in later development, especially as the company focuses on cutting costs.
But 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 is looking for a successor to Dolsten, who is leaving after more than 15 years at the drugmaker. Dolsten played a crucial role in the development of Pfizer’s Covid vaccine.