Italfarmaco Group

Italfarmaco Announces Topline Data from Phase 2 Trial with Givinostat in Patients with Becker Muscular Dystrophy

Retrieved on: 
Saturday, June 26, 2021
Research, Hospitals, Genetics, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Other Science, Muscular dystrophy, Branches of biology, Health, Medicine, Becker muscular dystrophy, Dystrophin, Givinostat, Dystrophy, Duchenne muscular dystrophy, Duchenne, BMD, Becker Muscular Dystrophy, Givinostat, Italfarmaco Group, BECKER MUSCULAR DYSTROPHY, GIVINOSTAT, ITALFARMACO GROUP

Italfarmaco Group announced today topline data from its proof-of-concept Phase 2 trial with Givinostat, the companys proprietary histone deacetylase (HDAC) inhibitor, in 51 adult males with Becker Muscular Dystrophy (BMD).

Key Points: 
  • Italfarmaco Group announced today topline data from its proof-of-concept Phase 2 trial with Givinostat, the companys proprietary histone deacetylase (HDAC) inhibitor, in 51 adult males with Becker Muscular Dystrophy (BMD).
  • The topline data was presented by Paolo Bettica on June 26, 2021, at the virtual Parent Project Muscular Dystrophy (PPMD) Annual Conference .
  • The Phase 2 trial investigating Givinostat in BMD patients was a randomized, double-blind, placebo-controlled study (ClinicalTrials.gov: NCT03238235 ).
  • Italfarmaco is also investigating the effect of Givinostat treatment in patients with Duchenne Muscular Dystrophy (DMD) in a Phase 3 trial (ClinicalTrials.gov: NCT02851797 ).

Italfarmaco Provides Update on Ongoing Clinical Programs with Givinostat in Oral Presentation at XVIII International Conference on Duchenne and Becker Muscular Dystrophy

Retrieved on: 
Monday, February 22, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical trials, Muscular dystrophy, Branches of biology, Health, Medicine, Becker muscular dystrophy, Duchenne muscular dystrophy, Duchenne, Givinostat, Dystrophy, Dystrophin, Golodirsen, Draft:Edasalonexent, Givinostat, Italfarmaco Group

The Italfarmaco Group announced updates on its clinical development programs with Givinostat, its proprietary histone deacetylase (HDAC) inhibitor, in boys with Duchenne Muscular Dystrophy (DMD), at the virtual XVIII International Conference on Duchenne and Becker Muscular Dystrophy.

Key Points: 
  • The Italfarmaco Group announced updates on its clinical development programs with Givinostat, its proprietary histone deacetylase (HDAC) inhibitor, in boys with Duchenne Muscular Dystrophy (DMD), at the virtual XVIII International Conference on Duchenne and Becker Muscular Dystrophy.
  • We are grateful to the clinical teams conducting the studies in all of the sites for continuing to work for the benefit of the participants.
  • The on-going, long-term study (ClinicalTrials.gov: NCT03373968 ) with Givinostat in boys with DMD is an extension of the companys Phase 2 trial (ClinicalTrials.gov: NCT01761292 ).
  • It is being evaluated for safety and efficacy for the treatment of Duchenne- and Becker- Muscular Dystrophy.

Italfarmaco Receives FDA Rare Pediatric Disease Designation for Givinostat in Duchenne Muscular Dystrophy, Announces Completed Enrollment in EPIDYS Phase 3 Trial

Retrieved on: 
Friday, October 9, 2020
Research, FDA, Hospitals, Clinical trials, Biotechnology, Other Health, Health, Other Science, Science, Orphan drugs, Drugs, Antibiotics, Health care, Health, Mesoblast, Regenerative biomedicine, Givinostat, Italfarmaco Group

The U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease designation to Givinostat for the treatment of DMD, which allows an expedited review process for new treatment modalities.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease designation to Givinostat for the treatment of DMD, which allows an expedited review process for new treatment modalities.
  • We are also pleased to have completed enrollment in our Phase 3 trial with 179 boys.
  • With trial enrollment completed, the last patient is expected to complete the 72-week treatment period in the first quarter of 2022.
  • Italfarmaco is expected to report topline data from the Phase 3 EPIDYS trial in June 2022.

Italfarmaco Provides Update on Advanced-Stage Clinical Development Program with Givinostat in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, April 27, 2020
Health, Other Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, RTT, Medicine, Health, Orphan drugs, Duchenne muscular dystrophy, Givinostat, Dystrophy, Duchenne, Muscular dystrophy, Becker muscular dystrophy, Drisapersen, Givinostat, Italfarmaco Group

The Italfarmaco Group provided today an update on the clinical development program of Givinostat, its proprietary histone deacetylase (HDAC) inhibitor, in Duchenne Muscular Dystrophy.

Key Points: 
  • The Italfarmaco Group provided today an update on the clinical development program of Givinostat, its proprietary histone deacetylase (HDAC) inhibitor, in Duchenne Muscular Dystrophy.
  • The EPYDIS Phase 3 clinical trial is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of Givinostat in patients with DMD.
  • It is being evaluated for safety and efficacy for the treatment of Duchenne- and Becker- Muscular Dystrophy.
  • Through both marketed drugs and compounds in development, Italfarmaco is dedicated to serving patients whose needs remain largely unmet.