Italfarmaco reports positive data from the EPIDYS trial and its ongoing open-label extension of givinostat in Duchenne

Italfarmaco reported new data from the Phase 3 EPIDYS trial, showing that quantitative MRI measures of muscle mass and fat fraction were significantly different between the treatment and placebo groups.  Interim analyses from the open-label extension study also indicate a delay in loss of ambulation (LoA), with median age of LoA =17.33 years with treatment, compared to published natural history data LoA = 11-13.4 years.  

Givinostat is available in the US as Duvyzat, from ITF Therapeutics.

Link to press release here: https://www.biospace.com/press-releases/presentation-of-new-clinical-data-on-givinostat-in-duchenne-muscular-dystrophy-at-icnmd-2026