Pfizer Inc. (NYSE: PFE) shares moved earthward on announcing its decision to continue to progress one oral late-stage glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidate toward further clinical development for the potential treatment of adults with obesity and Type 2 diabetes mellitus (T2DM). Moving forward, the company will continue advancing the clinical program for danuglipron (PF-06882961), subject to results from the ongoing Phase 2 trial, and discontinue the clinical development of lotiglipron (PF-07081532). The company expects to finalize plans for the danuglipron late-stage program by the end of 2023 and also is developing a once-daily modified release version.
Results previously published in the Journal of the American Medical Association Network Open from the Phase 2 study ( NCT03985293 ) of danuglipron in T2DM showed dose-dependent placebo-adjusted reductions (doses ranging from 2.5 mg through 120 mg for 16 weeks) in HbA1c of up to -1.16%; fasting plasma glucose of -33.24 mg/dL; and body weight of -4.17 kg over 16 weeks. The most common adverse events were nausea, vomiting and diarrhea. The Phase 2b study of danuglipron in non-diabetic obesity participants is currently ongoing (doses ranging from 40 mg through 200 mg for up to 32 weeks) and expected to complete by end of year. The safety profile of danuglipron to date, including transaminase changes, appears to be similar to the peptidic GLP-1R agonist class.
PFE shares stumbled $1.86, or 4.9%, to $36.44.