Italfarmaco To Seek Givinostat Approvals After Phase III Success In DMD

Capricor Reported Long-Term Data For Its Cell Therapy

 
• By Mandy Jackson
  
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Italfarmaco’s HDAC inhibitor helped ambulatory Duchenne muscular dystrophy patients climb stairs faster than non-treated boys while Capricor’s cell therapy improved upper limb function in non-ambulatory patients.

Young male physiotherapist helping patient with lifting dumbbells exercises in office
Italfarmaco's givinostat succeeded across all muscle function measures • Source: Shutterstock

Positive results for two novel therapies designed to improve muscle function in Duchenne muscular dystrophy (DMD) were presented over the weekend at the Parent Project Muscular Dystrophy (PPMD) annual conference, including Phase III data for Italfarmaco Group’s HDAC inhibitor givinostat. The private Italian drug developer plans to meet soon with the US Food and Drug Administration and European Medicines Agency to discuss filings based on the Phase III EPIDYS trial results.

Both Italfarmaco and Capricor Therapeutics, Inc. presented data on 25 June at the PPMD meeting, with Capricor reporting one-year...

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