NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) said that CIFFREO, a Phase 3
global, multicenter, randomized, double-blind, placebo-controlled study
evaluating the investigational mini-dystrophin gene therapy, fordadistrogene
movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did
not meet its primary endpoint of improvement in motor function among boys 4 to 7
years of age treated with the gene therapy compared to placebo.

The primary endpoint in the final analysis was assessed by change in the North
Star Ambulatory Assessment at one year after treatment.

Key secondary endpoints, including 10-meter run/walk velocity and time to rise
from floor velocity, also did not show a significant difference between
participants treated with fordadistrogene movaparvovec and placebo.

The company noted that the overall safety profile of fordadistrogene
movaparvovec in the CIFFREO trial was manageable, with mostly mild to moderate
adverse events, and treatment-related serious adverse events generally
responding to clinical management.

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