Bial Completes Phase 2b ACTIVATE Study of Potential First-in-Class GBA1 Parkinson's Treatment
Key Insights
Bial (search) has completed the 78-week treatment period of its Phase 2b ACTIVATE study evaluating BIA 28-6156 (pariceract (search)) in 273 patients with GBA1-associated Parkinson's disease (search).
The study enrolled genetically confirmed GBA-PD patients across 85 clinical sites in 11 countries throughout Europe and North America with strong patient retention rates.
BIA 28-6156 is being developed as a first-in-class, once-daily oral allosteric activator of beta-glucocerebrosidase (search) that may directly target the underlying cause of GBA1-associated Parkinson's disease (search).
Portuguese biopharmaceutical company Bial (search) has completed the treatment period of its Phase 2b ACTIVATE study evaluating BIA 28-6156 (pariceract (search)) in patients with GBA1-associated Parkinson's disease (search), marking a significant milestone in the development of what could be the first disease-modifying therapy specifically targeting this genetic form of the neurodegenerative disorder.
The 78-week double-blind treatment period enrolled 273 genetically confirmed GBA-PD patients across 85 clinical sites in 11 countries throughout Europe and North America over approximately 18 months. The study reported strong patient retention, reflecting the commitment of patients and study site teams throughout the extended trial period.
Targeting the Genetic Root of Parkinson's Disease
BIA 28-6156 is being developed as a first-in-class, small molecule for once-daily oral administration that functions as an allosteric activator of beta-glucocerebrosidase (search) (GCase (search)). By increasing the activity of GCase, the drug may be the first to directly modify the underlying cause of the disease in this patient population by re-establishing sphingolipid recycling.
"We are hopeful that BIA 28-6156 may help address a major unmet need by targeting the underlying cause of GBA1 (search)-associated Parkinson's," said Raquel Costa, Head of Clinical Operations and study lead at Bial (search).
Addressing a Critical Patient Population
GBA1 (search) mutations represent the largest genetic risk factor for Parkinson's disease (search), affecting between 5-15% of all Parkinson's patients. This patient population faces particular challenges, as GBA-PD patients tend to have an earlier onset of symptoms compared to those with idiopathic Parkinson's disease and experience more severe clinical symptoms that progress significantly faster, leading to a worse overall prognosis.
Parkinson's disease (search) is the second most common neurodegenerative disorder, affecting more than 10 million people worldwide. The genetic subset represented by GBA1 (search) mutations thus represents a substantial population with significant unmet medical needs.
Study Design and Objectives
The ACTIVATE study is evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in patients with GBA-PD. Upon completion of all scheduled safety follow-ups, data cleaning and analysis are currently ongoing, with topline results expected to be released around the end of Q2 2026.
Building Scientific Momentum
A status report on the ACTIVATE study was presented in an oral presentation at the 3rd International GBA1 (search) Meeting 2026, and the Bial (search) team is currently attending the 7th World Parkinson Congress in Phoenix from May 24-27, 2026.
"Momentum is building across the Parkinson's scientific community around the clinical potential of pariceract (search). At the GBA1 (search) Meeting and the 7th World Parkinson Congress, we have been able to connect with this community as we approach a key milestone, the anticipated release of topline results from our ACTIVATE study," Costa noted.
Company Focus on Neurosciences
Bial (search), an innovation-driven biopharmaceutical 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 a R&D center at its headquarters in Portugal, with affiliates across Europe and presence in the United States and selected emerging markets.
The company is also presenting additional research at the World Parkinson Congress, including posters on patient perspectives on treatment routines and adherence, and new insights from a Phase IV study on opicapone's effects on sleep and non-motor symptoms in Parkinson's patients.