Prilenia registers first subject for Phase 3 study of PROOF-HD in Europe

Prilenia Therapeutics B.V.- a clinical-stage biotech firm that focuses on developing advanced treatment solutions for neurodevelopment and neurodegenerative disorders, has announced the enrollment of the first volunteers its Phase 3 clinical study for Huntington’s Disease (HD) in Europe.  

For the record, the trial is being carried out across 60 sites in collaboration with the Huntington Study Group in Europe and North America. The first set of volunteers to carry out the PROOF-HD trial were signed-up in October 2020.

Citing reliable sources, PROOF-HD will take part at 30 facilities across nine countries in Europe, namely Czech Republic, Italy, Germany, France, Austria, Poland, Netherlands, Spain, and the UK. All the European nations have been granted national approval to carry out the trial.   

Apparently, the first participant was registered at the George Huntington Institute or GHI in Münster, Germany. This innovative protocol design that includes virtual visits will allow the study to continue unaffected even if a lockdown is imposed by the government authorities due to the prevailing coronavirus pandemic.

It may be noted that the trial is a randomized, placebo-controlled, double-blind, Phase 3 study that focuses on evaluating the safety and efficacy of pridopidine 45 mg bid in patients diagnosed with early-stage HD. The first endpoint is Total Functional Capacity.

Seemingly, this global clinical study will witness the participation of 480 people aged 25 or more with a clinical diagnosis of adult-onset HD across Europe and North America. The period of treatment is expected to last up to 78 weeks and there will also be an optional open-label extension.   

A first-in-class selective Sigma 1 – receptor agonist, Pridopidine has been developed by Prilenia in the treatment of neurodegenerative disorders like Amyotrophic Lateral Sclerosis and HD.

In addition to the above, PROOF-HD has been developed to duplicate the previous findings indicating that pridopidine showcases a favorable effect on the maintenance of functional capacity in patients with early signs of HD.

Reportedly, the proposed trial dose of 45 mg bid carries a favorable safety profile based on more than 1,000 patient-years in the previous HD trials.

Source Credit: https://www.businesswire.com/news/home/20210128005105/en/Prilenia-Enrolls-First-Subject-in-Europe-in-its-PROOF-HD-Phase-3-Clinical-Trial-for-Huntington%E2%80%99s-Disease