Prilenia Enrolls First Subject in Europe in its PROOF-HD Phase 3 Clinical Trial for Huntington’s Disease
NAARDEN, The Netherlands - January 28, 2021. Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announces the enrollment of the first participant in Europe in its global Phase 3 clinical trial for HD. The study is being conducted in 60 sites in collaboration with the Huntington Study Group (HSG) in North America and Europe. The first US subjects in the PROOF-HD trial were enrolled in October 2020.
PROOF-HD will take place at 30 sites across nine countries in Europe: Austria, Czech Republic, France, Germany, Italy, the Netherlands, Spain, Poland, and the UK. National approval has been granted in all European countries. The first participant was enrolled at George Huntington Institute (GHI) in Münster, Germany. The innovative protocol design, including virtual visits, will allow the study to continue undisrupted in case of any potential lockdown situations during the ongoing COVID-19 pandemic.
The study is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of pridopidine 45 mg bid in patients with early-stage HD. The primary endpoint is Total Functional Capacity. The global study will enroll a total of 480 participants aged 25 years or older with a clinical diagnosis of adult-onset HD in North America and Europe. The treatment period will last up to 78 weeks and there will be an optional open-label extension.
PROOF-HD is designed to replicate previous findings demonstrating that pridopidine shows a beneficial effect on the maintenance of functional capacity in patients with early HD. The trial treatment dose (45 mg bid) has a favorable safety profile based on over 1,000 patient years in previous HD trials.
Pridopidine is a first-in-class highly selective Sigma 1-receptor (S1R) agonist developed by Prilenia for the treatment of neurodegenerative disorders such as HD and Amyotrophic Lateral Sclerosis (ALS). Pridopidine binds and activates the S1R, a protein that is expressed at high levels within the brain and regulates key cellular pathways, commonly impaired in neurodegeneration. Recent analyses of previous PRIDE-HD and Open-HART trial results have shown positive data with regards to pridopidine on Total Function Capacity.
About Prilenia (www.prilenia.com)
Prilenia is a clinical stage biotech startup founded in 2018 with the purpose of improving the lives of patients and their families by developing treatments for neurodegenerative and neurodevelopmental disorders. Prilenia raised $ 88.5 million thus far and is backed by a group of well-respected investors: Talisman, Forbion, Morningside and Sectoral and ALS Investment Fund. The Company is based in Naarden, the Netherlands, Herzliya, Israel and Boston, MA in the U.S.
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