Huntington’s Disease: Prilenia Enrolls First Patients into PROOF-HD Clinical Trial
On October 28th, in an official press release, Prilenia Therapeutics , a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, announced the enrollment of the first patients in the U.S. into PROOF-HD, a global phase 3 clinical trial for Huntington’s Disease (HD).
Pridopidine Outcome On Function in Huntington’s Disease (PROOF-HD) is a randomized, double-blind, placebo-controlled, phase 3 study evaluating the efficacy and safety of pridopidine 45mg bid in patients with early stage HD, according to the TFC (Total Function Capacity Scale).
The study is being conducted in collaboration with the Huntington Study Group (HSG). It will enroll 480 participants aged 25 or older with a clinical diagnosis of adult-onset HD. The treatment period will last up to 78 weeks and there will be an optional open-label extension.
The trial will involve approximately 60 study centers in the U.S., Canada and Europe, included Italy and it will be coordinated by IRCCS Casa Sollievo della Sofferenza, with Ferdinando Squitieri, through the Mendel Genetic Center, located in Rome.
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