Porto, Portugal (OTE) – 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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Digital press kit: http://www.ots.at/pressemappe/PR178143/aom