Bial's Phase 2b ACTIVATE Study Reaches 75% Completion Milestone for GBA1-Associated Parkinson's Disease Treatment
Key Insights
Bial (search) announced that 75% of patients in its Phase 2b ACTIVATE study have completed the double-blind treatment period through week 78, marking a significant milestone toward completion.
The study is evaluating BIA 28-6156, a first-in-class oral allosteric activator of beta-glucocerebrosidase (search), in 273 genetically confirmed GBA1-associated Parkinson's disease (search) patients across 85 sites in 11 countries.
Topline results are expected in mid-2026, with the potential to deliver the first disease-modifying treatment that directly addresses the underlying cause of GBA1-associated Parkinson's disease (search).
Bial (search) has achieved a significant operational milestone in its Phase 2b ACTIVATE study, with 75% of enrolled patients completing the double-blind treatment period through week 78. The Portuguese biopharmaceutical company is evaluating BIA 28-6156, a potential first-in-class treatment for GBA1-associated Parkinson's disease (search) (GBA-PD), with topline results expected in mid-2026.
Study Progress and Timeline
The ACTIVATE study (ClinicalTrials.gov identifier: NCT05819359) is evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in patients with Parkinson's disease (search) who have a pathogenic mutation in the glucocerebrosidase 1 (GBA1 (search)) gene. The Last Patient, Last Visit (LPLV) is anticipated in April 2026, with topline results on track for release in mid-2026.
"We look forward to presenting data from our Phase 2b study. BIA 28-6156 is the leading asset in GBA-PD, and clinical outcomes are just around the corner," said António Portela, CEO of Bial (search). "We are witnessing growing enthusiasm across the Parkinson's community and are truly excited to be at the forefront of a potential and much-needed disease-modifying treatment for people living with GBA-PD."
Robust Patient Enrollment and Retention
The study demonstrates exceptional patient engagement, with recruitment completed ahead of expectations. A total of 273 genetically confirmed GBA-PD patients were enrolled over approximately 18 months across 85 clinical sites in 11 countries throughout Europe and North America. The study is reporting strong patient retention despite its long duration and complexity, reflecting both patient commitment and high-quality study conduct across sites.
Bial (search) has maintained regular communication with trial participants through newsletters distributed via clinical sites every three to four months or upon achievement of key milestones, demonstrating the company's commitment to transparency and patient engagement.
Addressing a Critical Unmet Medical Need
Parkinson's disease (search) is the second most common neurodegenerative disorder, affecting more than 10 million people worldwide. Between 5-15% of PD patients have mutations in the GBA1 (search) gene, making it the largest genetic risk factor for Parkinson's disease. GBA-PD patients tend to have an earlier onset of symptoms compared to those with idiopathic PD and experience more severe clinical symptoms that progress significantly faster, leading to a worse overall prognosis.
The rapid recruitment for the ACTIVATE study underscores the strong engagement of the global Parkinson's disease (search) community and highlights the substantial unmet medical need for disease-modifying therapies targeting GBA1-associated Parkinson's disease (search).
First-in-Class Therapeutic Approach
BIA 28-6156 is being developed as a first-in-class, small molecule for once-daily oral administration. The drug functions as an allosteric activator of beta-glucocerebrosidase (search) (GCase (search)), potentially representing the first treatment to directly modify the underlying cause of the disease in GBA-PD patients by re-establishing sphingolipid recycling.
By increasing the activity of GCase (search), BIA 28-6156 may address the fundamental pathological mechanism underlying GBA1-associated Parkinson's disease (search), offering hope for a disease-modifying treatment rather than merely symptomatic relief.
Company Commitment to Neurosciences
Bial (search), an innovation-driven pharmaceutical company focused on neurosciences and rare diseases, consistently invests over 20% of its annual revenue in research and development. The company operates manufacturing facilities and an R&D center at its headquarters in Portugal, with subsidiaries across Europe and presence in the United States and selected emerging markets. Bial's products are currently available in more than 50 countries.