What's Happening?
Bial, a biopharmaceutical company focused on neurosciences and rare diseases, has announced a significant milestone in its Phase 2 clinical study, ACTIVATE, which evaluates the efficacy and safety of BIA 28-6156 for Parkinson's disease patients with a GBA1 gene mutation. The study has enrolled 273 patients across 85 sites in Europe and North America, with 73 patients completing the 78-week double-blind treatment period. Over 80% of participants have reached the one-year treatment milestone, marking progress in developing new treatment options for Parkinson's Disease, particularly for those with GBA1 mutations. The trial is expected to conclude in April 2026, with topline results anticipated in the second quarter of the same year.
Why It's Important?
The advancement in the ACTIVATE trial is crucial for Parkinson's disease research, particularly for patients with GBA1 mutations, who often experience more severe symptoms. BIA 28-6156, a first-in-class small molecule, aims to modify the disease's underlying cause by increasing the activity of beta-glucocerebrosidase, potentially offering a disease-modifying treatment. This development could significantly impact the treatment landscape for Parkinson's disease, providing new hope for patients with genetic mutations that exacerbate their condition. The trial's success could lead to improved therapeutic options and better quality of life for affected individuals.
What's Next?
The trial is set to conclude with the last patient visit by April 2026, and topline results are expected in the second quarter of the same year. Bial's participation in the International Congress of Parkinson’s Disease and Movement Disorders in Honolulu will further disseminate findings and foster collaboration within the scientific community. The company plans to present a scientific poster comparing non-motor symptom progression in sporadic versus GBA-PD patients, which could provide additional insights into the disease's progression and treatment.
