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).

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 3^rd International GBA1 Meeting 2026. The team is currently attending the 7^th World Parkinson 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 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 7^th World Parkinson 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

About Bial

Bial is an innovation-driven pharmaceutical company dedicated to improving the health and lives of people worldwide. With a strong commitment to therapeutic innovation, Bial has established an ambitious R&D programme, consistently investing over 20% of its annual revenue in this area. The company focuses on two key areas with high unmet medical needs: neurosciences and rare diseases.

In Europe, Bial operates manufacturing facilities and a R&D centre at its headquarters in Portugal, and maintains affiliates in Spain, Germany, the United Kingdom, Italy, and Switzerland. In addition, Bial is present in the United States and selected emerging markets. As part of its international growth strategy, the company collaborates with established partners through strategic alliances and licensing agreements to expand access to its healthcare solutions.

Currently, Bial’s products are available in more than 50 countries, advancing its mission to pursue scientific excellence, mainly in neurosciences and rare diseases, delivering transformative medicines that empower patients’ lives.

For more information about BIA 28-6156, please visit: https://www.bial.com/en/our-research/pipeline/bia-28-6156

For more information about the trial design, please visit: www.clinicaltrials.gov (identifier: NCT05819359)

For more information about Bial, please visit: www.bial.com

References

1. den Heijer JM et al. Br J Clin Pharmacol. 2021 Sep;87(9):3561-3573
2. Guedes L. et al. Integrated safety analysis of BIA-28-6156 phase 1 clinical trials (a novel allosteric activator of beta-glucocerebrosidase). Presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS), Copenhagen, Denmark. August 27–31, 2023
3. APDA, www.apdaparkinson.org/what-is-parkinsons, accessed May 18^th 2026
4. Smith L, Schapira AHV. Cells. 2022 Apr 8;11(8):1261
5. Gan-Or Z, et al. Neurology. 2015 Mar 3;84(9):880-7

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