Bial Achieves Key Milestone in Phase 2b ACTIVATE Study of BIA 28-6156 in GBA1-Associated Parkinson’s Disease

Bial, an innovation-driven biopharmaceutical company focused on neurosciences and rare diseases, today announced that 75% of patients currently enrolled in its ongoing Phase 2b clinical study ACTIVATE (ClinicalTrials.gov identifier: NCT05819359) have completed the double-blind treatment period through week 78.

This operational milestone represents a significant step toward the completion of the ACTIVATE study, which is 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 date of the Last Patient, Last Visit (LPLV) is anticipated in April 2026, with topline results on track to be released in mid-2026.

“We look forward to presenting data from our Phase 2b study. BIA 28-6156 is the leading asset in GBA-PD, and clinical outcomes are just around the corner,” said António Portela, CEO of Bial. “We are witnessing growing enthusiasm across the Parkinson’s community and are truly excited to be at the forefront of a potential and much-needed disease-modifying treatment for people living with GBA-PD.”

The study is reporting strong patient retention, despite its long duration and complexity. This reflects the commitment of participating patients, as well as the high quality and robustness of study conduct across sites. As part of its commitment to transparency and patient engagement, Bial has maintained regular communication with trial participants through newsletters distributed via clinical sites every three to four months or upon achievement of key milestones.

“We are deeply grateful to the patients and their families for their extraordinary commitment, and to the global clinical community whose efforts continue to drive progress for people living with GBA-PD,” added António Portela.

Recruitment for the ACTIVATE study was completed ahead of expectations, with 273 genetically confirmed GBA-PD patients enrolled over approximately 18 months across 85 clinical sites in 11 countries throughout Europe and North America. This rapid recruitment underscores the strong engagement of the global Parkinson’s disease community and highlights the substantial unmet medical need for disease-modifying therapies targeting GBA1-associated Parkinson’s disease.

PD is the second most common neurodegenerative disorder affecting more than 10 million people worldwide.⁽¹⁾ Between 5-15% of PD patients have mutations in the GBA1 gene, making it the largest genetic risk factor for PD.⁽²⁾

GBA-PD patients tend to have, on average, an earlier onset of symptoms compared to those with idiopathic PD,⁽³⁾ and have more severe clinical symptoms that progress significantly faster, leading to a worse overall prognosis,⁽²⁾ thus emphasising the importance of developing new treatments for this condition.

About BIA 28-6156

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. ^(4,5)

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.

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 BIA28-6156, please visit: https://www.bial.com/com/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. APDA, www.apdaparkinson.org/what-is-parkinsons, accessed October 30 2024
2. Smith L, Schapira AHV. Cells. 2022 Apr 8;11(8):1261
3. Gan-Or et al., 2015; Grabowski, 2008
4. den Heijer JM et al. Br J Clin Pharmacol. 2021 Sep;87(9):3561-3573;
5. 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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