Bial Reports Topline Results From ACTIVATE Phase 2b Study in GBA‑Associated Parkinson’s

Bial, an innovation-driven biopharmaceutical company focused on neurosciences and rare diseases, announced today that the Phase 2b ACTIVATE study of BIA 28-6156 (pariceract) in patients with Parkinson’s who have a pathogenic variant in the GBA1 gene (GBA-PD) did not meet its primary, nor the key secondary efficacy endpoints, meaning that BIA 28-6156 failed to slow the progression of GBA-PD versus placebo. BIA 28-6156 proved to be generally well tolerated in the study, with no unexpected safety concerns arising.

While the study data provide valuable scientific information and contribute to a broader understanding of Parkinson’s biology, BIA 28-6156 did not demonstrate significant differentiation from placebo on the primary or key secondary endpoints measured. Based on the lack of demonstrated efficacy in this study, Bial has made the decision to discontinue further development of BIA 28-6156 for this indication.

“We are disappointed with the outcome of the Phase 2b ACTIVATE study, as the results do not confirm the hypothesis under investigation. I would like to express our gratitude to the study participants, their families and caregivers, the investigators, all the sites involved, and our teams for making this trial possible. We remain committed to finding treatments that could change disease progression for people living with Parkinson’s,” said António Portela, Chief Executive Officer of Bial.

Bial is dedicated to responsibly and transparently communicating these clinical research results. The ACTIVATE data will be disseminated through appropriate scientific channels, including peer-reviewed publications and scientific meetings.

“While we would have hoped for better news for the broader Parkinson’s community, the ACTIVATE study provides many valuable insights and learnings for the field, being crucial for enhancing our understanding of Parkinson's. We will use these findings to inform the community and to accelerate our efforts to develop new therapeutic solutions in this indication,” said Joerg Holenz, Chief Scientific Officer of Bial.

The ACTIVATE study evaluated the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of BIA 28-6156 in patients with GBA-PD. 273 genetically confirmed GBA-PD patients were enrolled over approximately 18 months across 85 clinical sites in 11 countries throughout Europe and North America.

BIA 28-6156 was 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.

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

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We are disappointed with the outcome of the Phase 2b ACTIVATE study, as the results do not confirm the hypothesis under investigation.