Pfizer to Discontinue P-III (REALM-DCM) Trial of PF-07265803 for the Treatment of LMNA-Related Dilated Cardiomyopathy


The company will stop the P-III (REALM-DCM) trial to evaluate the efficacy and safety of PF-07265803 (p38α MAPK antagonist) in patients with symptomatic DCM due to a mutation of the gene encoding LMNA
The decision was based on the results of interim futility analysis which indicated that the P-III trial failed to meet its 1EPs. Additionally, PF-07265803’s development will be discontinued, based on the P-III trial results
Additionally, enrolled patients will stop receiving study treatment and complete any required follow-up assessments. The company is actively working with regulatory authorities globally, investigators, and community groups regarding the discontinuation

Ref: Pfizer | Image: Pfizer