Pfizer Ditches Cardiomyopathy Drug After Trial Miss

Pfizer says it is discontinuing the development of PF-07265803 in patients with symptomatic dilated cardiomyopathy (DCM) after an interim futility analysis of the global Phase 3 trial REALM-DCM indicated that it is unlikely to meet the primary endpoint upon completion. The trial was designed to evaluate the investigational compound’s efficacy and safety in patients with symptomatic DCM who have a mutation of the gene encoding the lamin A/C protein (LMNA). The primary outcome measure was a change from baseline in the six-minute walk test at 24 weeks, which is a measure of participant exercise tolerance as an estimate of functional capacity, according to the company.

PF-07265803 is described as a potent and selective, oral, small-molecule inhibitor of the p38α mitogen activated protein kinase pathway. The therapy had demonstrated improvement in functional capacity (six-minute walk test) in a 48-week, open-label, Phase 2 study among patients with symptomatic LMNA-related DCM. Pfizer obtained PF-07265803 from Array Biopharma in a 2019 acquisition.