BIAL Marks Milestone in Phase 2 Trial of BIA 28-6156 for Parkinson’s

BIAL Celebrates Key Milestone in Parkinson's Disease Treatment

BIAL, an established innovative biopharmaceutical company, recently announced a significant advancement in the clinical research for GBA1 Parkinson's Disease. The foremost patient has successfully completed the treatment regimen in the ACTIVATE Phase 2 study, marking a notable step in the quest for effective therapies.

Introducing BIA 28-6156

BIA 28-6156 is a groundbreaking small molecule therapy, designed for once-daily oral administration. This innovative treatment acts as an allosteric activator of beta-glucocerebrosidase (GCase), specifically aimed at patients with Parkinson's disease caused by mutations in the glucocerebrosidase 1 (GBA1) gene. By enhancing GCase activity, it aims to directly address the root causes of the disease through improved sphingolipid recycling.

Expert Insights on the ACTIVATE Study

Joerg Holenz, the Chief Scientific Officer at BIAL, expressed enthusiasm regarding this milestone: "The first patient out in the ACTIVATE study is a pivotal achievement in the development of BIA 28-6156. We're hopeful that this treatment can provide groundbreaking options for patients battling neurodegenerative diseases. This medication potentially offers a specific, disease-modifying action that may slow down motor progression for those diagnosed with GBA-PD."

What Does the ACTIVATE Study Involve?

The ACTIVATE study is a multicenter, randomized, double-blind, placebo-controlled trial assessing the effectiveness, safety, and tolerability of BIA 28-6156. Participants will be given two fixed doses: 10mg/day and 60mg/day. Initial results are anticipated to be shared mid-2026, creating excitement within both the medical community and patient advocates.

The Impact of GBA1 Mutations

Parker's disease stands as the second most prevalent neurodegenerative disorder worldwide, affecting over 10 million people. Notably, 5-15% of these cases involve GBA gene mutations, which represent a critical genetic risk factor. Patients with these mutations typically experience earlier symptom onset, more acute clinical manifestations, and a faster disease progression, underscoring the urgency for new treatment modalities.

Significance of BIA 28-6156

BIA 28-6156, formerly known as LTI-291, is designed to activate GCase, thereby restoring essential metabolic processes affected by Parkinson's disease. Its formulation allows for oral administration with minimal toxicity, demonstrating the capacity to navigate the blood-brain barrier – a critical hurdle for many neurological treatments.

Commitment to Research and Development

BIAL R&D is deeply committed to advancing research in neurodegenerative diseases. This Portuguese company focuses on developing innovative therapies while leveraging its rich history and expertise encompassing drug discovery and clinical assessment. With numerous proprietary compounds under investigation, including BIA 28-6156, BIAL aims to play a pivotal role in delivering novel health solutions.

The Vision of BIAL

Pioneering therapeutic innovations, BIAL has consistently invested over 20% of its annual revenue into research and development. The company seeks to broaden its global presence through collaborations and partnerships, striving to make a tangible difference in the lives of those affected by serious health challenges.

Frequently Asked Questions

What is BIA 28-6156 designed to treat?

BIA 28-6156 is developed for treating Parkinson's disease patients with mutations in the GBA1 gene.

Who leads the Phase 2 ACTIVATE study?

BIAL's Chief Scientific Officer, Joerg Holenz, and other notable experts are overseeing the study.

What are the expected outcomes from the ACTIVATE study?

The study aims to evaluate the efficacy, safety, and tolerability of BIA 28-6156, with initial findings projected for mid-2026.

Why are GBA1 mutations significant in Parkinson's disease?

Mutations in GBA1 are the most critical genetic risk factors for the development of Parkinson's disease, leading to more severe symptoms and faster progression.

What sets BIA 28-6156 apart from other treatments?

BIA 28-6156 is designed to directly modify the disease mechanism, potentially offering a disease-modifying treatment for GBA-PD patients.

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