Pfizer, a leading pharmaceutical company, announced on Thursday that it will be advancing with a once-daily version of its weight loss pill, danuglipron. The decision came after the company received “encouraging” data from an ongoing early-stage study. Pfizer evaluated various once-daily formulations of the drug and identified one that showed the most favorable safety profile and reaction from the body.
To further determine the ideal dosage of the drug, Pfizer plans to conduct additional early-stage trials in the second half of this year. The results of these trials are expected to be available in the first quarter of next year. These trials will play a significant role in the registration enabling studies, which are crucial for regulatory approval.
Dr. Mikael Dolsten, the outgoing Chief Scientific Officer of Pfizer, expressed confidence in danuglipron, stating that it has demonstrated good efficacy in a twice-daily formulation. He believes that a once-daily formulation has the potential to be competitive in the oral GLP-1 (glucagon-like peptide-1) space. Importantly, Pfizer did not observe any liver safety issues in patients who received once-daily formulations of the drug.
Pfizer is among several pharmaceutical companies competing to gain market share in the rapidly growing market for GLP-1 agonists, which are drugs used for weight loss and diabetes treatment. Analysts estimate that this market could be worth around $100 billion by the end of the decade. However, Pfizer has faced challenges in entering this market.
In December, Pfizer discontinued a twice-daily version of danuglipron due to tolerability issues reported by patients in a mid-stage study. However, the company remained optimistic about the once-daily version and stated that data from early studies would guide its path forward. Despite this, investor sentiment regarding Pfizer’s potential in the GLP-1 space has been pessimistic, particularly after the company halted a different once-daily pill in June 2023 due to elevated liver enzymes in patients.
Nevertheless, Pfizer continues to work on other experimental obesity drugs in the early stages of development. These treatments have not been disclosed, but Dr. Dolsten emphasized that obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of candidates.
Pfizer’s CEO, Albert Bourla, also believes that GLP-1s are just the beginning of what we will see in terms of obesity treatment. He stated during a conference in June that the company sees significant potential in this area.
Pfizer’s danuglipron is part of the GLP-1 class of drugs, which promote weight loss by mimicking a hormone called GLP-1 produced in the gut. This hormone signals to the brain when a person is full. Currently, injectable GLP-1 drugs from Novo Nordisk and Eli Lilly have seen growing demand despite their high costs and limited insurance coverage. Pfizer, along with other drugmakers, is racing to develop oral versions of these drugs to provide more convenience for patients and address supply shortages.
Pfizer has previously mentioned the possibility of acquiring or partnering with a smaller obesity drugmaker. However, Bourla stated that the company is unlikely to purchase an obesity treatment in later stages of development due to its focus on cost-cutting. Instead, Pfizer is exploring potential licensing deals or earlier-stage weight loss drugs.
This update on danuglipron comes as Pfizer searches for a successor to Dr. Dolsten, who will step down after more than 15 years at the company. He played a pivotal role in the development of Pfizer’s successful COVID-19 vaccine.
In conclusion, Pfizer’s decision to move forward with a once-daily version of danuglipron shows its commitment to the weight loss and diabetes market. Despite previous setbacks, the company remains optimistic about the potential of its GLP-1 drug and believes it can have a competitive profile. Pfizer’s ongoing research and development efforts in the obesity space reflect its dedication to addressing the growing need for effective weight loss treatments.
