Pfizer has decided to discontinue the clinical development of PF-07265803 for the treatment of patients with symptomatic dilated cardiomyopathy due to a mutation of the gene encoding the lamin A/C protein (LMNA).
PF-07265803 is an investigational selective, oral, small molecule inhibitor of the p38a mitogen activated protein kinase pathway. The multinational, randomized, double-blind, placebo-controlled REALM-DCM trial (ClinicalTrials.gov Identifier: NCT03439514) evaluated the efficacy and safety of PF-07265803 in patients with symptomatic LMNA-related dilated cardiomyopathy.
The decision to discontinue was made based on an interim futility analysis that showed the trial was unlikely to meet its primary endpoint of change from baseline in the 6-minute walk test at 24 weeks. The decision was not based on safety concerns.
“This development confirms the complexity of advancing new treatments for rare cardiovascular diseases and the need to further increase knowledge in this space,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “Although this outcome is disappointing, Pfizer remains committed to continuing our work to evolve the treatment paradigm for patients with rare cardiovascular diseases.”
Detailed trial data will be presented at future medical meetings.
Pfizer to discontinue development program for PF-07265803 for LMNA-related dilated cardiomyopathy. News release. Pfizer Inc. Accessed August 4, 2022. https://www.pfizer.com/news/announcements/pfizer-discontinue-development-program-pf-07265803-lmna-related-dilated
This article originally appeared on MPR