Bial, a biopharma company focused on innovation in neurosciences and rare diseases, has shared updates on its Phase 2 study named ACTIVATE (NCT05819359). This trial is evaluating BIA-28-6156 in individuals with Parkinson’s disease who have a harmful GBA1 (GBA-PD) mutation, looking at the drug’s safety, effectiveness, and how it works in the body.

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So far, the trial has recruited 273 patients who have been confirmed to have the genetic mutation, with enrollment taking place at 85 locations across Europe and North America. Seventy-three participants have finished the 78-week double-blind treatment phase, and more than 80% have now passed their one-year mark in the study. These achievements show that the trial is moving forward as planned. The final visit for the last patient is expected by April 2026, with main results anticipated in the second quarter of that year.

BIA-28-6156 is an experimental, once-daily oral treatment that works by activating beta-glucocerebrosidase (GCase). This drug aims to improve GCase function, which could help correct the biological issue causing disease progression in GBA-PD patients by restoring sphingolipid recycling.

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Raquel Costa, Head of Clinical Operations and lead of the study, said, “All patients reaching week 52 is a highly meaningful milestone. This brings us closer to obtaining the data needed to rigorously assess the safety and efficacy of BIA-28-6156, which could become a much-needed disease-modifying treatment for this patient population.”

In addition, Bial has announced it will present a poster at the upcoming International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Honolulu, from October 5 to 9. The poster will compare the progression of non-motor symptoms in people with sporadic Parkinson’s disease versus those with GBA-PD, showing that symptoms tend to worsen more quickly and severely in GBA-PD patients over a six-year period.

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