Key big pharma player Pfizer has decided to discontinue the development of its oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron, due to safety concerns.
The therapeutic, which was being investigated for its role in long-term weight management and obesity, demonstrated a competitive efficacy and tolerability profile durig phase III testing when taken twice daily.
However, during the study — although the overall frequency of liver enzyme elevations within the safety database fell in line with approved agents in this class — a single participant receiving danuglipron experienced potential drug-induced liver injury, which resolved after discontinuation of a twice-daily danuglipron regimen.
After reviewing the available information and seeking the advice of key regulatory bodies, the pharmaceutical compay has decided to discontinue danuglipron's development.
"While we are disappointed to discontinue the development of danuglipron, we remain committed to evaluating and advancing promising clinical programmes in an effort to bring new medicines to patients," commented Pfizer's Chief Scientific Officer and President of R&D, Chris Boshoff.
"Cardiovascular and metabolic diseases — including obesity — remain important areas of unmet medical need, and we plan to continue advancing our pipeline of investigational treatments that have the potential to fill critical gaps in patient care."
"This includes the continued development of our oral GIPR antagonist candidate, as well as our earlier obesity programmes," he added.
According to Pfizer, data from the danuglipron programme will either be presented at an undisclosed upcoming scientific forum, or submitted for publication in a peer-reviewed journal.