BIAL's Landmark Phase 2 Trial in Parkinson’s Disease
In a groundbreaking advancement for Parkinson's disease (PD) treatment, BIAL, a century-old biopharmaceutical firm specializing in neuroscience, has achieved a major milestone by completing the first full dosage regimen in its Phase 2 clinical study of BIA 28-6156. This innovative small molecule therapy specifically targets patients who possess a mutation in the glucocerebrosidase 1 (GBA1) gene, commonly known as GBA-PD. This population, constituting approximately 5-15% of PD patients, typically experiences a more aggressive disease trajectory, underlining the necessity for tailored interventions.
Understanding BIA 28-6156
BIA 28-6156 is a first-of-its-kind, orally administered allosteric activator designed to enhance the activity of beta-glucocerebrosidase (GCase). The research suggests that by improving GCase function, this therapy could directly address and potentially modify the pathophysiology of GBA-PD—bridging a much-needed gap in existing treatment options.
Joerg Holenz, BIAL's Chief Scientific Officer, expressed optimism about the study’s implications, stating that achieving the first patient out of the ACTIVATE study represents a landmark event not only for the trial but for the broader community of those affected by neurodegenerative disorders. He stated, "We are confident that our medicine has the potential to become a groundbreaking, novel treatment for patients with a confirmed diagnosis of GBA-PD."
The ACTIVATE Study
The ACTIVATE study, classified as a Phase 2 multicenter, randomized, double-blind, placebo-controlled trial, aims to assess the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of two fixed doses of BIA 28-6156 (10 mg/day and 60 mg/day). Over 230 genetically confirmed GBA-PD patients are participating across 85 sites in Europe and North America. Initial findings are expected by mid-2026, creating significant anticipation among the scientific community and patients alike.
Joaquim Ferreira, an investigator from the Lisbon School of Medicine and part of the ACTIVATE Steering Committee, reflected on the study's progress, noting its essential role in advancing options for PD treatment, particularly for patients with GBA mutations. His sentiments echo the collective hope for innovative solutions that address the specific needs of these patients, who often present with more severe symptoms compared to those with idiopathic PD.
The Impacts of GBA Mutations
The significance of GBA1 mutations in the context of Parkinson's disease cannot be overstated. The mutations have been established as one of the most critical genetic risk factors associated with the development of the disease. Patients with these mutations tend to display earlier onset and a faster progression of clinical symptoms, which can considerably affect their quality of life. The focus on developing therapies like BIA 28-6156 that could potentially alter the disease's course is optimistic and necessary.
BIA 28-6156 has demonstrated a favorable safety profile in previous studies and is prepared to cross the blood-brain barrier, which is crucial for the effectiveness of PD therapies. As BIAL continues to navigate the complexities of drug development, its dedication to R&D in neurodegenerative diseases remains unwavering.
About BIAL
BIAL - RD Investments S.A., a subsidiary of BIAL Holding, is committed to the research and development of new treatments for various medical conditions, primarily focusing on neurodegenerative diseases. The company invests more than 20% of its annual revenue into R&D, emphasizing its commitment to therapeutic advancement. BIAL's comprehensive strategy includes establishing partnerships and licensing agreements, ensuring that the innovative solutions it develops can reach those in need worldwide.
For further details and updates about BIA 28-6156 and the ongoing clinical trials, please visit
BIAL's official website and look up the specific clinical trial on
clinicaltrials.gov with identifier NCT05819359.