According to a company press release, Pfizer has stopped work on the cardiovascular disease candidate after its phase 3 analysis. This futility analysis of the phase 3 trial that is designed to check the effectiveness and safety of PF-07265803 will be aborted mainly due to safety concerns. This failure is due to the variations in making the lamin A/C protein.
Pfizer has started communicating with the regulatory authorities, community groups, and investigators about the discontinuation of their trials. With the guidance of the investigators, all patients registered in the Phase 3 trial will stop the medications and complete all follow-up examinations. A full detailed study from the REALM-DCM will be presented at future medical meetings as it will help any ongoing research.
“The recent development confirms the complications that may arise in the advancing new treatments for rare cardiovascular diseases and the need to increase knowledge in this area,” said Chris Boshoff, M.D., Ph.D., the Chief Development Officer for Oncology and Rare Disease in Pfizer Global Product Development. Boshoff thanked all the patients, their families, investigators, and members of the advocacy community for their contribution to this research.
Summary of the Phase 2 studies and PF-07265803
Phase 2 is a study involving two groups that check the safety and effectiveness of PF-07265803 in patients with symptomatic LMNA-related DCM. The initial result is measured through a basic six-minute walk test for 24 weeks. It is to check the patient’s exercise tolerance to estimate their functional capacity.
Pfizer picked up PF-07265803 from Array Biopharma in a US$ 114.4 billion takeover in 2019. It was previously called ARRY-371797, an investigational compound being studied for treating symptomatic cardiovascular disease resulting from the LMNA gene mutation. It is a strong, oral, small-molecule inhibitor of the p38a mitogen that activates a protein that showed improvement in the 6-minute walk test in 48 weeks Phase 2 study among patients with symptomatic LMNA-related DCM.