PORTO, Portugal, June 2, 2025 /PRNewswire/ -- BIAL, an innovation-driven biopharmaceutical company focused on neurosciences and rare diseases, today announced that it will give an oral presentation on its potential disease-modifying compound, BIA 28-6156, at the GBA1 Meeting 2025 being held June 5-7, 2025, in Montreal, Canada. The GBA1 Meeting 2025 is hosted by McGill University, focusing on all aspects of GBA1 research, from basic science to clinical trials.

BIAL will be presenting the ACTIVATE study, a Phase II trial evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in patients with Parkinson's disease (PD) who have a mutation in the glucocerebrosidase 1 (GBA1) gene (GBA-PD). The presentation will happen in the session "Small molecules targeting GBA1" and will focus on study design, genetic testing, recruitment challenges, and trial status.

Raquel Costa, the study lead, comments, 'We're witnessing a growing enthusiasm around the potential of BIA 28-6156 across the Parkinson's community and are eager to present further insights into the ACTIVATE study design at the upcoming GBA1 Meeting. We believe this investigational therapy could represent a significant step forward with the potential to be a much-needed disease-modifying treatment option for patients living with GBA-PD.'

BIA 28-6156 is a first-in-class, small molecule for once-daily oral administration, allosteric activator of beta-glucocerebrosidase (GCase), in development 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).

The ACTIVATE study (clinicaltrials.gov: NCT05819359) is a Phase II, multicenter, randomised, double-blind, placebo-controlled study evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in GBA-PD patients. The study has enrolled 273 genetically confirmed GBA-PD patients, several of whom have already completed the trial, across 85 sites in Europe and North America. Topline data from this Phase II study is expected to be released in the second quarter of 2026.

Presentation Details:

Date and Time: June 5, 2025; 12:00-12:20 PM
Session: Small molecules targeting GBA1 - session 2
Presenter: Raquel Costa, Senior Manager, Clinical Operations, BIAL
Location: Delta Hotels, Montreal

About BIAL
BIAL is a 100-year-old 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: https://www.bial.com/com/our-research/pipeline/bia-28-6156
For more information about the trial design: http://www.clinicaltrials.gov (identifier: NCT05819359)
For more information about BIAL: 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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