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.
