Italfarmaco has provided an update regarding the Givinostat clinical trial for the Duchenne community:

• The Interim data from EPYDIS Phase 3 trial shows that the trial is not futile and the Independent Data Monitoring Committee recommends trial continuation.
• Blinded re-estimation of the study sample size allows a reduction of the total number of subjects to be enrolled.
• Analyses of the long-term study with Givinostat suggest a delay in disease progression.

Recruitment is now open to:

• Individuals with a confirmed diagnosis of Duchenne muscular dystrophy
• 6 years old+
• Able to walk (no criteria on distance or speed)

There are currently nine spots available.

To find out more about eligibility for this program, please contact one of the three trial sites in Canada as soon as possible:

Alberta

• Kinsmen Research Centre – Alberta Children’s Hospital – Alberta Health Services (contact: Dr. Jean Mah – jean.mah@albertahealthservices.ca)

British Columbia

• The University of British Columbia – Children’s and Women’s Health Centre of BC Branch (contact: Dr. Kathryn Selby – kselby@cw.bc.ca)

Ontario

• Holland Bloorview Kids Rehabilitation Hospital (contact: Dr. Laura McAdam – lmcadam@hollandbloorview.ca)

Note: Due to COVID-19, enrollment is currently paused, but sites are still evaluating eligibility for future planned screening.

There is also a Givinostat clinical trial open for individuals with a confirmed diagnosis of Becker muscular dystrophy between 18 to 65 years of age. Please contact Italfarmaco for more information: patientadvocacy@italfarmaco.com.

Please see the full media release here.

About Givinostat

Givinostat is an investigational drug that helps activate muscle repair. Early clinical trials have shown Givisostat to decrease inflammation, increase regeneration, and decrease fat and fibrosis in the muscle.

Givinostat is an investigational drug discovered through Italfarmaco’s internal research and development efforts in collaboration with Lorenzo Puri (SanfordBurnhamPrebys Medical Research Institute, San Diego, formerly Santa Lucia Foundation, Rome) and his team, and partnerships with Telethon and Parent Project aps. It is being evaluated for safety and efficacy for the treatment of Duchenne- and Becker- Muscular Dystrophy. Givinostat inhibits histone deacetylases (HDACs). HDACs are enzymes that prevent gene translation by changing the three-dimensional folding of DNA in the cell. Studies show that Duchenne patients have higher than normal HDAC levels, which may prevent muscle regeneration, and also trigger inflammation. In the company’s clinical study in DMD boys aged seven to less than 11 years, Givinostat was observed to slow disease progression, significantly increase muscle mass and reduce the amount of fibrotic tissue. Givinostat treatment also significantly reduced muscle tissue necrosis and fatty replacement, two additional parameters related to disease progression (Bettica et al., Neuromuscular Disorder 2016).

Read more about Givinostat here.

About Italfarmaco Group

Italfarmaco is a specialty pharmaceutical company engaged in the discovery, development, manufacturing and marketing of branded prescription and nonprescription products in more than 60 countries on 5 continents. Italfarmaco’s research and development expertise is best demonstrated through its HDAC inhibitor development programs, addressing new therapeutic treatments of specialty and rare diseases. Through both marketed drugs and compounds in development, Italfarmaco is dedicated to serving patients whose needs remain largely unmet.

Read more about Italfarmaco Group here.

Contacts

Italfarmaco Group
Paolo Bettica, MD, PhD
Chief Medical Officer
+39 02 6443 2511
p.bettica@italfarmaco.com