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CompilationFan Dongdong
After the accidental death of a patient, Pfizer has announced the suspension of the screening and administration of a Phase Ib trial of experimental gene therapy PF-06939926 for the treatment of Duchenne muscular dystrophy (DMD)
On Monday, the pharmaceutical giant announced that a patient died in a fixed cohort participating in the company's phase Ib mini-dystrophin gene therapy trial
As the US FDA suspended the trial, this will directly slow down the company's progress in submitting an investigational new drug application
Pfizer said in a statement that the safety and well-being of patients in the gene therapy PF-06939926 clinical trial remains the top priority of Pfizer and will be committed to sharing more information about the death with the medical and patient groups as soon as possible.
It is unclear whether the death event will affect the ongoing Phase III CIFFREO study in outpatient boys with DMD.
In October 2020, the gene therapy PF-06939926 received the Fast Track designation from the US FDA, and also received the Orphan Drug and Rare Pediatric Therapy designation from the agency
Currently, the United States has approved five therapies for the treatment of DMD, each of which targets a subset of the patient population
Reference source: Pfizer Halts DMD Gene Therapy Trial to Uncover Cause of Patient Death
