BioVie Inc., a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, has announced results from the phase 2 trial evaluating its drug candidate bezisterim in early-stage Parkinson’s disease (PD).
The trial was a phase 2, multicentre, randomised, double-blind, placebo-controlled trial designed to establish proof-of-mechanism and proof-of-concept in patients with early-stage PD that had not previously been treated with carbidopa/levodopa.
Under the statistical analysis plan submitted to the US Food and Drug Administration (FDA), the study’s primary pharmacodynamic assessment focused on changes in a predefined panel of blood-based inflammatory markers of disease.
The study also evaluated motor and non-motor endpoints, clinician-rated outcomes, quality-of-life and safety and tolerability measures to assess bezisterim’s activity and clinical profile in early PD, with the goal of informing the design of a potentially pivotal phase 3 trial.
The trial successfully met prespecified endpoints and achieved its objectives, with topline results showing that bezisterim improved blood based inflammatory markers of disease, along with a broad range of biological markers associated with overall cellular health and nerve cell damage. Participants treated with bezisterim experienced greater improvements than those receiving placebo across a series of clinical outcome measures of daily living, motor symptoms and non-motor symptoms.
The majority of patients treated with bezisterim showed improvement on EPNIC-15, a composite endpoint encompassing 15 clinically relevant motor and non-motor measures of PD. In contrast, patients receiving placebo showed a change in the opposite direction.
