Pfizer announced on Thursday that the company would proceed with the launch of a once-daily version of its weight-loss pill danugliprone after seeing “encouraging” data in an ongoing early-stage trial.
The company evaluated several once-daily forms of the drug and identified the one with the “most favorable profile” in terms of safety and the body’s response to the drug.
Pfizer plans to conduct more early-stage trials in the second half of the year to determine the ideal dose of the drug. Results are expected in the first quarter of next year, a spokesperson told CNBC. The company said those trials would “serve as the basis for the pivotal trials” used in applications for regulatory approval.
Danugliprone “has demonstrated good efficacy in a twice-daily formulation, and we believe a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space,” Pfizer's outgoing chief scientific officer, Dr. Mikael Dolsten, said in a press release. Notably, the company has not observed any liver safety issues in patients receiving a once-daily formulation of the drug.
Pfizer is one of several drug companies vying for market share in GLP-1 agonists, a hugely popular class of weight-loss and diabetes drugs, and some analysts predict the industry will be worth around $100 billion by the end of the decade.
But Pfizer has so far had difficulty gaining a foothold in the market.
The pharmaceutical giant stopped the twice-daily version of danugliprone in December after patients in a mid-stage trial had problems tolerating the drug. At the time, Pfizer said early trial data on the once-daily version “provided a path forward.”
But investors have been pessimistic about the company's potential in the GLP-1 space since it pulled another once-daily pill from the market in June 2023 because patients receiving the treatment had elevated liver enzymes. Those setbacks were just one of many Pfizer experienced last year, in addition to the rapid decline in its Covid business, which dragged down the company's stock.
Still, Pfizer has other experimental obesity drugs in early development. The company has not disclosed how these treatments will work.
“Obesity is an important therapeutic area for Pfizer and the company has a robust pipeline with three clinical and several preclinical candidates,” Dolsten said in the press release.
Pfizer also believes GLP-1 is only “scratching the surface of what we're going to see in the obesity space,” CEO Albert Bourla said during a conference in June.
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Pfizer’s Danugliprone is a GLP-1 that promotes weight loss in the same way as Novo Nordisk's injection Wegovy and diabetes treatment Ozempic. The drugs mimic a single hormone produced in the gut called GLP-1, which signals to the brain when a person is full.
Injections from Novo Nordisk and Eli Lilly Demand for these vehicles has increased sharply over the past year, despite their high price and limited insurance coverage.
The team is working with Pfizer and other pharmaceutical companies to develop oral versions that are more convenient for patients to take and easier to manufacture, which could help alleviate supply shortages in the United States.
Pfizer had previously stated that the company could acquire or partner with a smaller obesity drug maker.
At a conference in January, Bourla told reporters that Pfizer was unlikely to buy an obesity drug in late-stage development, especially as the company looks to cut costs.
However, he said Pfizer is looking for potential licensing deals or early-stage weight-loss drugs.
Pfizer's update on danugliprone comes days after the company announced it was seeking a successor to Dolsten, who will step down after more than 15 years at the drugmaker. Dolsten played a crucial role in the development of Pfizer's Covid vaccine.
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