Pfizer recently announced that an interim futility analysis of the global phase-III trial, REALM-DCM, designed to evaluate the efficacy and safety of PF-07265803 in patients with symptomatic dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA), indicated the trial is unlikely to meet its primary endpoint upon completion. Based on these results, the phase-III trial and further development of PF-07265803 will be discontinued. The decision is not based on safety concerns, a statement from the company notified.
The company is communicating with worldwide regulatory authorities, investigators and community groups regarding the discontinuation. Under their investigator’s guidance, patients enrolled in the phase-III trial will stop study medication and complete any necessary follow-up evaluations. Detailed data from the REALM-DCM study will be presented at future medical meetings to help inform ongoing research, added the statement.