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Pfizer on Thursday mentioned it’s going to transfer ahead with a once-daily model of its weight reduction tablet, danuglipronafter it noticed “encouraging” information in an ongoing early-stage research.
The corporate evaluated a number of once-daily formulations of the drug and recognized one with “the most favorable profile” when it comes to security and the way the physique reacts to the drug.
Pfizer mentioned it plans to conduct extra early-stage trials within the second half of the yr to establish the best dose of the drug, with outcomes anticipated within the first quarter of subsequent yr, a spokesperson informed CNBC. The corporate mentioned these trials will “inform the registration enabling studies,” that are utilized in purposes for regulatory approval.
Outcomes are anticipated within the first quarter of subsequent yr, a spokesperson informed CNBC.
Danuglipron “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,” outgoing Pfizer Chief Scientific Officer Dr. Mikael Dolsten mentioned in a launch. Notably, the corporate didn’t observe any liver issues of safety in sufferers who obtained once-daily formulations of the drug.
Pfizer is considered one of a number of drugmakers racing to win a slice of the marketplace for a extremely in style class of weight reduction and diabetes medicine referred to as GLP-1 agonists. Some analysts anticipate the business to be value roughly $100 billion by the tip of the last decade.
However Pfizer has to this point struggled to interrupt into the market.
The pharmaceutical big in December discontinued a twice-daily model of danuglipron after sufferers had hassle tolerating the drug in a mid-stage research. On the time, Pfizer mentioned early research information on the once-daily model would “inform a path forward.”
However buyers have been pessimistic in regards to the firm’s potential within the GLP-1 area ever because it scrapped a unique once-daily tablet in June 2023 because of elevated liver enzymes in sufferers who obtained the therapy. These had been amongst a string of setbacks Pfizer confronted final yr on high of the speedy decline of its Covid enterprise, which battered its inventory.
Nonetheless, Pfizer has different experimental weight problems medicine in early levels of improvement. The corporate has not disclosed how these remedies will work.
“Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates,” Dolsten mentioned within the launch.
Pfizer additionally believes GLP-1s are solely “scratching the surface of what we will see in obesity,” CEO Albert Bourla mentioned throughout a convention in June.
Pfizer’s danuglipron is a GLP-1 that promotes weight reduction in the identical manner as Novo Nordisk’s injection Wegovy and diabetes therapy Ozempic. The medicine mimic a single hormone produced within the intestine referred to as GLP-1, which indicators to the mind when an individual is full.
Injections from Novo Nordisk and Eli Lilly have soared in demand over the past yr regardless of their hefty value tags and restricted insurance coverage protection.
The pair – together with Pfizer and different drugmakers – have been racing to develop oral variations which can be extra handy for sufferers to take and simpler to fabricate, which may assist alleviate provide shortages within the U.S.
Pfizer has beforehand mentioned it may purchase or associate with a smaller weight problems drugmaker.
Bourla informed reporters at a convention in January that it was unlikely the corporate would purchase an weight problems therapy in later-stage improvement, particularly as the corporate focuses on reducing prices.
However he mentioned Pfizer was on the lookout for potential licensing offers or earlier-stage weight reduction medicine.
Pfizer’s replace on danuglipron comes days after the corporate mentioned it’s looking for a successor to Dolsten, who will step down after greater than 15 years on the drugmaker. Dolsten performed a vital position in growing Pfizer’s Covid vaccine.
