BIAL Advancements: Phase 2 Trial for GBA1 Parkinson's Drug Makes History with First Patient Completion

BIAL Achieves First Patient Milestone in Phase 2 Trial of BIA 28-6156

BIAL, an esteemed biopharmaceutical firm with a century-long legacy and a focus on neurology and rare diseases, recently marked a significant achievement in its Phase 2 clinical trial of BIA 28-6156, an innovative treatment for GBA1 Parkinson's Disease (PD). The company announced that the first patient has successfully completed the required dosage regimen in the study, referred to as ACTIVATE.

Understanding BIA 28-6156

BIA 28-6156 is a unique small molecule oral medication that works as an allosteric activator of beta-glucocerebrosidase (GCase), with the potential to address the root cause of Parkinson's disease in individuals with a GBA1 mutation. The drug aims to enhance GCase enzyme activity, which is crucial for proper sphingolipid recycling in cells, a process often disrupted in patients with GBA-PD.

Joerg Holenz, Chief Scientific Officer at BIAL, emphasized the importance of this milestone, stating, "The first patient out in the ACTIVATE study marks a pivotal milestone in the development of BIA 28-6156, as well as for our ambition to create transformative value for people living with neurodegenerative diseases." Holenz expresses confidence in the drug's ability to potentially delay the progression of this debilitating condition.

The ACTIVATE Study

The ACTIVATE trial, officially registered under clinicaltrials.gov with the identifier NCT05819359, is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate various aspects of BIA 28-6156, including its efficacy, safety, and tolerability. The study is testing two dosage levels: 10mg and 60mg per day.

Looking ahead, BIAL expects to release top-line data from this exciting phase 2 study in mid-2026. Joaquim Ferreira, a professor and ACTIVATE study investigator, added that this completion is a promising development for both the GBA-PD patient group and the broader Parkinson's disease community.

The Significance of GBA1 Mutations

Globally, Parkinson's disease stands as the second most common neurodegenerative disorder, affecting over 10 million individuals. Notably, between 5 to 15 percent of those with PD possess mutations in the GBA gene, which is recognized as a significant genetic risk factor for the condition.

Patients carrying GBA1 mutations often display earlier symptom onset and a more rapid disease progression compared to those with idiopathic PD. Recognizing the urgent need for impactful therapies, the development of BIA 28-6156 is of particular importance.

Insights into BIA 28-6156

Previously known as LTI-291, BIA 28-6156 is characterized by its ability to cross the blood-brain barrier and low toxicity, which were confirmed through various in vitro and in vivo studies. Its potential to provide a disease-modifying treatment option makes it especially promising for patients diagnosed with GBA-PD.

The Role of BIAL

BIAL, a fully-integrated biopharmaceutical company, is committed to innovation and is dedicated to enhancing quality of life globally. With an increasing emphasis on research and development, the company allocates more than 20% of its annual revenue to this area, focusing on neurology and rare disease solutions.

As BIAL embarks on this new journey with BIA 28-6156, it seeks to forge paths not only for patients with GBA-PD but also for the entire Parkinson's community, aiming to offer hope through groundbreaking medical advancements.

For additional details concerning BIA 28-6156 and the ongoing clinical trial, you can visit BIAL's research pipeline and for trial specifics, check clinicaltrials.gov using identifier NCT05819359.