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August 4, 2022

Pfizer to discontinue Phase III dilated cardiomyopathy trial

The latest decision to discontinue the trial is not based on safety concerns linked to PF-07265803.

Pfizer has announced plans to discontinue the Phase III trial and development programme for PF-07265803 for lamin A/C protein (LMNA)-related dilated cardiomyopathy (DCM).

The latest move is based on data from an interim futility assessment of the Phase III REALM-DCM clinical trial.

According to the analysis data, the trial is not likely to meet its primary endpoint upon conclusion. 

The multinational, placebo-controlled trial is designed to assess the safety and efficacy of PF-07265803 in patients with symptomatic DCM due to a mutation of the LMNA encoding gene.

The variation from baseline in the six-minute walk test at 24 weeks is the trial’s primary outcome measure.

This test measures a subject’s exercise tolerance as a functional capacity estimate. 

Due to the latest findings, the trial and advanced development of PF-07265803 will be stopped. 

The company noted that the latest decision is not based on safety concerns linked to PF-07265803. 

Furthermore, Pfizer is communicating with global regulatory agencies, investigators and communities on the latest development. 

As per the guidance of the investigator, subjects enrolled in the trial will stop receiving study treatment and conclude any required follow-up assessments. 

An investigational compound, PF-07265803 is a potent and selective, oral, small-molecule inhibitor of the p38α mitogen-activated protein kinase pathway.

It is being analysed for treating symptomatic DCM due to an LMNA gene mutation.

After Array Biopharma’s acquisition by Pfizer in July 2019, the latter obtained PF-07265803. 

Pfizer Global Product Development Oncology and Rare Disease chief development officer Chris Boshoff said: “This development confirms the complexity of advancing new treatments for rare cardiovascular diseases and the need to further increase knowledge in this space.

“Although this outcome is disappointing, Pfizer remains committed to continuing our work to evolve the treatment paradigm for patients with rare cardiovascular diseases.”

In May this year, the company collaborated with Headlands Research to launch new research sites in regions with diverse populations to boost trial diversity.

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