Bial announced a significant milestone in its Phase 2 ACTIVATE clinical trial evaluating BIA 28-6156, a first-in-class treatment for patients with Parkinson's disease who carry pathogenic mutations in the glucocerebrosidase 1 (GBA1) gene. The Portuguese biopharmaceutical company reported that more than 80% of the 273 enrolled patients have reached the one-year treatment milestone, with 73 patients already completing the 78-week double-blind treatment period.
Trial Progress and Timeline
The ACTIVATE study (NCT05819359) has enrolled 273 genetically confirmed GBA-PD patients across 85 sites in Europe and North America. The trial is evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in this specific patient population. The last visit of the final patient is expected by April 2026, with topline results anticipated in the second quarter of 2026.
"All patients reaching week 52 of the study 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," said Raquel Costa, Head of Clinical Operations and study lead.
Novel Mechanism of Action
BIA 28-6156 is being developed as a small molecule for once-daily oral administration that functions as an allosteric activator of beta-glucocerebrosidase (GCase). By increasing GCase activity, the drug may become the first treatment to directly modify the underlying cause of disease in GBA-PD patients by re-establishing sphingolipid recycling.
This mechanism represents a potentially groundbreaking approach to treating GBA-associated Parkinson's disease, targeting the root cause rather than just managing symptoms.
Research Insights on Disease Progression
Complementing its clinical development program, Bial will present new research at the International Congress of Parkinson's Disease and Movement Disorders (MDS) in Honolulu from October 5-9, 2025. The company's poster presentation will compare non-motor symptom progression between sporadic and GBA-associated Parkinson's disease patients.
The research findings suggest that over a six-year period, symptoms are more severe and progress more rapidly in GBA-PD patients compared to those with sporadic Parkinson's disease. This data underscores the urgent need for targeted therapies for this patient population.
The poster, titled "A 6-year longitudinal analysis from the Parkinson's progression markers initiative on non-motor symptom severity and progression in GBA1-associated vs. sporadic Parkinson's disease," will be presented by Raquel Costa on October 8, 2025, at 11:36 AM.
Company Focus and Investment
Bial maintains a strong commitment to therapeutic innovation, consistently investing over 20% of its annual revenue in research and development. The company focuses on two key therapeutic areas with high unmet medical needs: neurosciences and rare diseases. Bial's products are currently available in more than 50 countries worldwide.
