Bial has announced a key operational milestone in its ongoing phase 2b ACTIVATE study evaluating BIA 28-6156 in patients with Parkinson’s disease associated with mutations in the GBA1 gene. The company confirmed that 75% of enrolled patients have now completed the double-blind treatment period through week 78.
The ACTIVATE study is assessing the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BIA 28-6156 in genetically confirmed GBA1-associated Parkinson’s disease, often referred to as GBA-PD. Completion of this stage of the trial marks a significant step towards study readout, with the last patient visit expected in April 2026 and topline results anticipated in mid-2026.
BIA 28-6156 is being developed as a once-daily oral, small-molecule allosteric activator of beta-glucocerebrosidase. By increasing the activity of this enzyme, the therapy aims to address a key biological mechanism underlying GBA-PD, potentially offering a disease-modifying approach rather than symptomatic relief alone.
The ACTIVATE study has demonstrated strong patient retention despite its long duration and complexity, which the company attributes to the commitment of participants, their families and clinical investigators. Bial has also highlighted its efforts to maintain patient engagement through regular study updates distributed via clinical sites.
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Recruitment to the trial was completed ahead of schedule, with 273 patients enrolled over approximately 18 months across 85 clinical sites in 11 countries in Europe and North America. The rapid enrolment reflects both high engagement within the Parkinson’s disease community and the substantial unmet need for targeted therapies in this population.
GBA1 mutations represent the most common genetic risk factor for Parkinson’s disease and are associated with earlier disease onset, more severe symptoms and faster progression compared with idiopathic Parkinson’s disease. These features underline the importance of developing treatments specifically aimed at this subgroup.
If successful, BIA 28-6156 could represent an important advance for people living with GBA1-associated Parkinson’s disease, for whom disease-modifying options remain limited.
This news item has been summarised using AI and checked by humans before publication.
Sources
Bial
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