BIAL R&D has dosed the first patient in its Phase II ACTIVATE study of BIA 28-6156 to treat patients with Parkinson’s disease (PD) with a mutation in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).
The placebo-controlled, randomised, multicentre, double-blind study will assess the tolerability, efficacy, and safety of two fixed-dose levels of BIA 28-6156 (10mg and 60mg/day), an allosteric activator of the enzyme beta-glucocerebrosidase (GCase).
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It will also evaluate the pharmacokinetics and pharmacodynamics of BIA 28-6156 in 237 genetically confirmed GBA-PD subjects.
Subjects with PD diagnosed between one to seven years before genetic screening are enrolled in the trial.
They will be randomised to one of the three treatment groups to receive BIA 28-6156 10mg, 60mg or placebo.
The study will assess the delay of meaningful clinical progression up to 78 weeks of the double-blind treatment period. It is measured using the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and Part III.
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By GlobalDataBIAL chief medical officer Nuno Mendonça said: “Activation of GCase enzymatic activity via allosteric modulation with BIA 28-6156 offers a novel potential treatment for patients with GBA-PD, as well as a promising new approach to delay clinical motor progression.
“Data from nonclinical settings, including data from human cells, suggest that activation of GCase enzymatic activity could provide therapeutic benefit to patients with PD who carry a GBA-PD risk-associated variant in the GBA1 gene.”
The company is planning to start screening patients in the EU in the third quarter of this year. The study is currently selecting patients across sites in North America.
