News & Views
Edison Pharmaceuticals begins Ataxia Clinical Trial
Jan 07 2013
Edison Pharmaceuticals has started a phase 2B study, which will investigate new treatments for Friedreich's ataxia.
The trial is entitled Safety and Efficacy Study of EPI-743 on Visual Function in Patients with Friedreich's Ataxia. It is placebo-controlled and will last six months, before an extension phase begins where subjects will receive EPI-743.
Those contruibuting to the clinical laboratory work need to be between 18 and 45 years of age, possess confirmation of the disease and meet particular disease severity criteria.
Its primary endpoint is visual function, while secondary endpoints include neurological and neuromuscular function, alongside disease-relevant biomarkers.
The trial is being carried out with help from Friedreich's Ataxia Research Alliance (FARA) Clinical Research Network and FARA's Patient Registry.
FARA president Ronald Bartek said that the company is looking forward to the commencement of the research.
"FARA is excited about the commencement of the EPI-743 Friedreich's ataxia clinical trial, and is working closely with Edison Pharmaceuticals and Clinical Research Network investigators to expedite enrolment.
"This trial represents the importance of public-private partnership in drug development and the culmination of FARA-sponsored translational research, initiated with both FARA and National Institutes of Health (NIH) support."
FARA clinical research network investigator Theresa Zesiewicz, professor of Neurology, director of the University of South Florida Ataxia Research Centre and one of the trial's principal investigators, also commented on the work.
"Given the encouraging clinical findings reported to date for EPI-743 in mitochondrial disease, we are eager to determine whether these results are distensible to Friedreich's ataxia," Ms Zesiewicz explained.
News of Edison Pharmaceuticals' latest trial comes after it received EP1-743 orphan designation from European Medicines Agency (EMA) to help treat Leigh Syndrome.
Edison has studied EPI-743 in 80 subjects with mitochondrial disease, with this data being used along with a phase 2A study to form the basis of the application.
The company will also soon release the results of its phase 2A study entitled Prospective Open Label Study of EPI-743 in Children with Leigh Syndrome (Subacute Necrotizing Encephalomyelopathy).
Digital Edition
LMUK 49.7 Nov 2024
November 2024
News - Research & Events News - News & Views Articles - They’re burning the labs... Spotlight Features - Incubators, Freezers & Cooling Equipment - Pumps, Valves & Liquid Hand...
View all digital editions
Events
Nov 11 2024 Dusseldorf, Germany
Nov 12 2024 Cologne, Germany
Nov 12 2024 Tel Aviv, Israel
Nov 18 2024 Shanghai, China
Nov 20 2024 Karachi, Pakistan