Bial Announces Completion of Phase 2b ACTIVATE Study with BIA 28-6156 in GBA1-Associated Parkinson’s

Bial, an innovation-driven biopharmaceutical company focused on neurosciences and rare diseases, today announced the completion of the treatment period in its Phase 2b ACTIVATE study of BIA 28-6156 (pariceract) in patients with Parkinson’s disease (PD) who have a pathogenic mutation in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

  • Study Topline results will be released around the end of Q2 2026

  • BIA 28-6156 is being developed as a potential first-in-class disease-modifying therapy in GBA-PD

  • Bial was present at the GBA1 conference and is currently attending the World Parkinson Congress

Upon completion of the 78-week double-blind treatment period and all scheduled safety follow-ups, data cleaning and analysis are currently ongoing. Topline results will be released around the end of Q2.

A status report on the ACTIVATE study was presented in an oral presentation at the 3rd International GBA1 Meeting 2026. The team is currently attending the 7th World Parkinson’s Congress, taking place in Phoenix from 24 to 27 May 2026.

“Momentum is building across the Parkinson’s scientific community around the clinical potential of pariceract. At the GBA1 Meeting and the 7th World Parkinson’s 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”, said Raquel Costa, Head of Clinical Operations and study lead.

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 reported strong patient retention, reflecting the commitment of patients and study site teams.

“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”, added Raquel Costa.

The ACTIVATE study is evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in patients with GBA-PD.

BIA 28-6156 is in development as a first-in-class, small molecule for once-daily oral administration, allosteric activator of beta-glucocerebrosidase (GCase), for the treatment of patients with GBA-PD. By increasing the activity of GCase, BIA 28-6156 may be the first drug to directly modify the underlying cause of the disease in this group of patients by re-establishing the sphingolipid recycling.(1,2)

Parkinson’s is the second most common neurodegenerative disorder, affecting more than 10 million people worldwide.(3) Between 5-15% of Parkinson’s patients have mutations in the GBA1 gene, making it the largest genetic risk factor.(4)

GBA-PD patients tend to have, on average, an earlier onset of symptoms compared to those with idiopathic Parkinson’s(5) and have more severe clinical symptoms that progress significantly faster, leading to a worse overall prognosis, (4) thus emphasising the importance of developing new treatments for this condition.

Translating Bial’s focus on Parkinson's Disease research and development, the company is also presenting two posters at the 7th World Parkinson's Congress, highlighting 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.

Posters Details:
Date:
26 May 2026
Session Time:
11:30 AM - 1:00 PM
Location: Room:
Hall D-E (3rd floor) - Phoenix Convention Center

Posters Title:
TRACK-PD: Understanding Treatment Routines and Adherence in Care - Knowledge and Perspectives of People Living with Parkinson’s Disease.
Effect of Opicapone on Sleep-Related Complaints and Non-Motor Burden in Parkinson’s Patients: A Post-Hoc Analysis of the OASIS Trial.

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