BioVie’s Alzheimer’s disease and Parkinson’s disease candidate NE3107 has shown efficacy again in trials.

A Phase IIa trial of the candidate in Parkinson’s disease and a Phase III trial of the candidate in Alzheimer’s disease have both reported further positive data, which is set to be announced in two presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 from 5 March to 9 March 2024 in Lisbon, Portugal.

The Phase IIa trial in Parkinson’s disease (NCT05083260) investigated NE3107 in combination with standard of care (SoC) levodopa. The data showed a significant effect on non-motor symptoms and motor control in the treatment group compared to placebo-treated patients, supporting previously reported data.

The data showed that NE3107 patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the non-motor symptom scale (NMSS) in Parkinson’s disease, whereas placebo patients experienced a worsening of +1 points.

Meanwhile, the company’s Phase III trial of the candidate in mild to moderate Alzheimer’s Disease (NCT04669028) suggests NE3107 may realign physiological processes in patients consistent with decreased neurocognitive decline and diseases of ageing.

There were issues with the Phase III trial, with BioVie reporting significant deviation from protocol and Good Clinical Practice violations were found at 15 sites and caused the exclusion of all patients from those sites. As a result, just 57 patients remained, with baseline and completion data available for 50 patients, 24 treated and 26 placebo.

BioVie says that because of the deviations, the trial missed statistical significance in cognitive and functional measures despite improvements observed.

Based on the promising signal from patients who did complete the trial, BioVie says it will work with the US Food and Drug Administration (FDA) to use the trial’s adaptive design to allow the continued enrollment of patients.

Chris Reading, senior vice-president of BioVie’s Alzheimer’s disease programs: “Principal component analyses, divergent correlations, and epigenetic analysis suggest that metabolic inflammation may be a driver of biological ageing and Alzheimer’s disease and that NE3107 might have the potential to realign physiological processes consistent with decreased neurocognitive decline and diseases of ageing.”

NE3107 is an oral molecule designed to block the activation of nuclear factor kappa B (NF-kappa-B) and extracellular signal-regulated kinases (ERK). The candidate acts by inhibiting the inflammatory ERK signalling pathway that reduces neuroinflammation.

Alzheimer’s and Parkinson’s disease landscape

The Alzheimer’s disease market across the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan and China) is set to grow from $2.2bn in 2020 to $13.7bn in 2030, according to a GlobalData report.

The drivers are expected to be the launch of new drugs including disease-modifying therapies, immunotherapies and novel symptomatic therapies, the development and validation of biomarkers and an ageing global population.

The Parkinson’s disease market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is set to grow from $3.4bn in 2019 to $6.4bn in 2029, according to a GlobalData report.

The growth will be driven by the growing ageing population coupled with the launch of 14 pipeline products across the 7MM.

GlobalData is the parent company of the Clinical Trials Arena.