Individuals with GBA-PD typically experience earlier onset and more severe symptoms, which progress faster. Credit: chainarong06 / Shutterstock.

BIAL has reported the completion of the full dose regimen for the first subject in the multicentre Phase II ACTIVATE trial of the allosteric activator of beta-glucocerebrosidase (GCase), BIA 28-6156 for treating individuals with Parkinson’s disease (PD).

This drug is being developed for PD patients with a glucocerebrosidase 1 (GBA1) gene (GBA-PD) mutation.

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Designed for one-time-a-day oral administration, BIA 28-6156 will re-establish sphingolipid recycling for modifying the underlying cause of PD.

The randomised, placebo-controlled, double-blind trial assesses the safety, pharmacodynamics, tolerability, pharmacokinetics, and efficacy of two fixed-dose levels of 10mg/day and 60mg/day of therapy.

With topline data anticipated in mid-2026, the trial is a pivotal part of the company’s research into PD treatments.

BIAL chief scientific officer Joerg Holenz said: “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.

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“We are confident that our medicine has the potential to become a groundbreaking, novel treatment for patients with a confirmed diagnosis of GBA-PD. BIA 28-6156 offers a specific, potentially disease-modifying mechanism of action, with the potential to delay clinical motor progression.”

BIAL R&D, a subsidiary of BIAL, is developing this therapy to treat PD in patients with a pathogenic mutation in the GBA1 gene. The molecule’s ability to cross the blood-brain barrier, combined with a low toxicity profile, has been validated through in vitro and in vivo studies, as well as extensive toxicology research.

PD affects more than ten million individuals globally and is the second most common neurodegenerative disorder in the US. Individuals with GBA-PD typically experience earlier onset and more severe symptoms, which progress faster.

In May 2023, BIAL R&D dosed the first subject in the ACTIVATE Phase II study.