On 8 March, at the AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases, during a symposium titled “Therapeutic Intervention in AD and PD”, BioVie presented results from its Phase III study (NCT04669028) of NE3107 in patients with mild-to-moderate probable Alzheimer’s disease (AD).
Given the complex nature of the pathophysiology of Alzheimer’s, key opinion leaders (KOLs) previously interviewed by GlobalData highlighted the importance of developing drugs with novel mechanisms of action that target different aspects of Alzheimer’s disease pathology as it will be crucial in providing a variety of treatment options for patients. NE3107 is an oral, anti-inflammatory and insulin sensitizer that acts by inhibiting extracellular signal regulated kinase (ERK 1 and 2). Inflammatory signaling driven by ERK 1 and 2 and Nuclear Factor Kappa B (NFκB) are believed to be major drivers of neurodegenerative disease, and NE3107 exclusively targets the inflammatory signaling of ERK and NFκB without inhibiting their homeostatic functions.
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Data presented at AD/PD 2024 confirmed the previously announced topline results that treatment with NE3107 resulted in improvements in both clinical outcomes and metabolic, inflammatory, and epigenetic biomarkers compared to placebo. Additionally, patients treated with NE3107 demonstrated “age deceleration” compared to the placebo group of around 4 years. Age deceleration is used by researchers to measure the difference between a person’s biological age and their actual chronological age. Chronological age is based on epigenetic DNA methylation biomarkers and is known as the DNA methylation clock. This age deceleration seen in NE3107-treated patients was also correlated with cognitive and functional improvements, measured using the Clinical Dementia Rating sum of boxes score (CDR-SB), as well as improvements in a range of metabolic parameters such as glucose, cholesterol, and insulin sensitivity. Further, NE3107 demonstrated a benign safety profile, with no treatment-related serious adverse events reported in the trial.
Despite the promising data announced, it is important to note a significant limitation of the trial. Significant deviation from protocol and Good Clinical Practice (GCP) violations were found at multiple trial sites, which resulted in the company removing the majority of the trial participants from the analysis with only 50 out of the 439 enrolled participants left in the final analysis, and the offending sites were referred to the FDA Office of Scientific Investigations. This reduction in participant numbers means that there were not enough participants to sufficiently power the trial analysis, and thus, despite showing positive trends of the benefits of treatment with NE3107 compared to placebo, BioVie highlighted that the results presented were not statistically significant and therefore the results presented remain a hypothesis of the potential effects of NE3107.
BioVie is planning a further Phase III study in which NE3107 will be required to demonstrate significant clinical effects compared to placebo in a much larger cohort of patients before the drug can be considered a truly promising novel option for patients with Alzheimer’s. However, if the hypotheses made from the trial data, that NE3107 might realign physiological processes consistent with decreased neurocognitive decline and diseases of aging, can be proven, this would represent a very exciting development in the treatment of Alzheimer’s disease.
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