Key Milestone in ACTIVATE Phase 2 Clinical Trial of BIA 28-6156

Bial, an innovation-driven biopharmaceutical company focused on neurosciences and rare diseases, today announced a significant milestone in its ongoing Phase 2 clinical study, ACTIVATE (clinicaltrials.gov: NCT05819359), evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in patients with Parkinson’s disease (PD) who have a pathogenic mutation in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

The ACTIVATE study has enrolled 273 genetically confirmed GBA-PD patients across 85 sites in Europe and North America. Seventy-three patients have already completed the double-blind treatment period of 78 weeks, and more than 80% of participants have now reached the one-year treatment milestone. These are important milestones to ensure a successful completion of the trial and a step forward in the clinical development of new treatment options for Parkinson’s Disease, particularly for patients with GBA1 mutations. The last visit of the last patient in the trial is expected by April 2026, with topline results anticipated in the second quarter of the same year.

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)

“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.

Translating Bial’s focus on Parkinson's Disease research and development, the company also announced its participation in the upcoming International Congress of Parkinson’s Disease and Movement Disorders (MDS), taking place October 5–9 in Honolulu, USA.

Bial will present a scientific poster comparing the progression of non-motor symptoms in patients with sporadic versus GBA-PD. Findings suggest that, over a six-year period, symptoms are more severe and progress more rapidly in GBA-PD patients compared to sporadic PD.

Poster Presentation Details:

• Title: “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”
• Date and Time: October 8, 2025; 11:36 AM
• Presenter: Raquel Costa, Senior Manager, Clinical Operations, Bial
• Poster Number: Nº 1260; Exhibit Hall 1 (Level 1)

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 an R&D centre at its headquarters in Portugal, and maintains subsidiaries 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.

Today, Bial’s products are available in more than 50 countries, advancing its mission to make a meaningful difference in the lives of people living with severe diseases.

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

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