Bial has completed the treatment in its Phase IIb ACTIVATE clinical trial evaluating BIA 28-6156 (pariceract) in Parkinson’s disease (PD) pents with a pathogenic mutation in the glucocerebrosidase 1 (GBA1) gene, GBA-PD.
The 78-week, double-blind treatment period ended after all scheduled safety follow-ups, with data cleaning and analysis now in progress.
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Top line results from the Phase IIb trial are anticipated by the end of the second quarter.
The study enrolled 273 genetically confirmed GBA-PD patients over 18 months across 85 clinical sites in 11 nations across North America and Europe.
Strong patient retention was observed, supported by the commitment of both patients and site teams.
Bial clinical operations head and study lead Raquel Costa said: “Momentum is building across the Parkinson’s scientific community around the clinical potential of pariceract.
“This is a particularly exciting moment for the whole Parkinson’s community and for Bial. We would like to sincerely thank the patients, their families, investigators, and site teams who contributed to the ACTIVATE with extraordinary commitment and rigour over the course of the study. We are hopeful that BIA 28-6156 may help address a major unmet need by targeting the underlying cause of GBA1-associated Parkinson’s.”
The ACTIVATE study is designed to assess the safety, efficacy, pharmacodynamics, pharmacokinetics, and tolerability of BIA 28-6156 in GBA-PD patients.
BIA 28-6156 is being developed as an allosteric activator of beta-glucocerebrosidase (GCase) for the once-daily oral treatment of GBA-PD.
In January 2025, Bial reported the completion of the full dose regimen for the first subject in the multi-centre Phase II ACTIVATE trial of BIA 28-6156 for treating individuals with PD.
