BIAL Marks Significant Milestone in Parkinson's Disease Study

BIAL Celebrates Phase 2 Milestone for Parkinson's Disease Treatment

BIAL, a century-old biopharmaceutical company known for its innovation in neurosciences and rare diseases, has reached a significant milestone in its clinical development. The company has announced that the first patient has successfully completed the full dose regimen in the ACTIVATE Phase 2 study of BIA 28-6156.

Understanding BIA 28-6156

BIA 28-6156 is a groundbreaking small molecule designed for once-daily oral administration. It acts as an allosteric activator of beta-glucocerebrosidase (GCase), which is essential in the treatment of patients diagnosed with Parkinson's disease (PD), especially those with mutations in the GBA1 gene. This innovative treatment aims to combat GBA-PD by potentially modifying the underlying causes of the disease, offering hope for enhanced patient outcomes.

The Impact on Parkinson's Disease

This drug works by increasing GCase activity, potentially re-establishing sphingolipid recycling within the body. Joerg Holenz, BIAL's Chief Scientific Officer, expressed enthusiasm about the completion of the first patient's treatment, emphasizing the significance of this achievement in the fight against neurodegenerative diseases. BIA 28-6156 could represent a transformative therapeutic option for those living with GBA-related Parkinson's disease.

Details of the ACTIVATE Study

The ACTIVATE study is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial. It evaluates the safety, tolerability, pharmacodynamics, and pharmacokinetics of two fixed-dose levels of BIA 28-6156 (10mg/day and 60mg/day). Topline results from this important study are anticipated in mid-2026, which will provide further insights into the drug's efficacy and safety profile.

Expert Opinions on the Milestone

Professor Joaquim Ferreira, involved in the study, shared that the completion of the first patient's treatment marks a critical juncture in developing new treatment options for Parkinson's disease, particularly for patients harboring GBA1 mutations. The recruitment phase has surpassed expectations, with over 230 genetically confirmed GBA-PD patients enlisted at 85 international sites, including those in Europe and North America.

The Relevance of GBA Mutations in Parkinson's Disease

Parkinson's disease is increasingly acknowledged as the second most prevalent neurodegenerative disorder, affecting over 10 million individuals worldwide. Among PD patients, 5-15% carry mutations in the GBA gene, which is recognized as a crucial genetic risk factor for the disease. These genetic links underscore the necessity for targeted treatment options, especially considering GBA-PD patients' tendency toward earlier onset and more severe symptom progression.

Exploring GBA-PD Symptoms

Patients with GBA mutations usually exhibit symptoms earlier than those with idiopathic PD and experience a more rapid clinical decline. This highlights the importance of developing effective solutions that can positively influence disease progression, ultimately improving the quality of life for affected individuals.

What Sets BIA 28-6156 Apart?

BIA 28-6156, formerly known as LTI-291, represents a novel class of GCase allosteric activators that enhance enzyme activity while maintaining a low toxicity profile. The formulation is designed for daily oral administration and has been validated through comprehensive in vitro and in vivo studies, demonstrating its potential to cross the blood-brain barrier effectively.

BIAL's Commitment to Research and Development

BIAL R&D Investments S.A., a Portuguese subsidiary of BIAL Holding, is dedicated to driving forward the research and development of innovative treatments for neurodegenerative diseases. With a focus on ensuring that cutting-edge therapies are available for patients, BIAL has been actively contributing to the clinical landscape through its extensive pipeline that includes BIA 28-6156.

About BIAL

As a biopharmaceutical company with over a century of experience, BIAL is committed to improving health worldwide through its extensive research initiatives. The company invests significantly in R&D, focusing on neurosciences and rare diseases. BIAL operates production and R&D facilities in Portugal and has its products distributed across more than 50 countries, aiming to make a meaningful difference in the lives of patients.

Frequently Asked Questions

What is BIA 28-6156?

BIA 28-6156 is a novel small molecule designed for the treatment of Parkinson's disease, specifically for patients with GBA1 mutations.

What milestone has BIAL achieved with BIA 28-6156?

BIAL announced that the first patient has completed the full dose regimen in the ACTIVATE Phase 2 study.

What is the ACTIVATE Phase 2 study?

The ACTIVATE study is a Phase 2 clinical trial evaluating the efficacy and safety of BIA 28-6156 in patients with GBA-PD.

What is the expected timeline for results from the trials?

Topline data from the Phase 2 ACTIVATE study is expected to be released in mid-2026.

Why are GBA mutations significant in Parkinson's disease?

Mutations in the GBA gene are one of the most common genetic risk factors for Parkinson's disease and can lead to a more severe form of the disease.

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