BioVie’s Alzheimer’s candidate shows potential impact in Phase 2 trial

BioVie announced data suggesting that NE3107 has an impact on improving patients’ DNA methylation profiles, potentially impacting biomakers of aging-related disease states. The Phase 2 trial enrolled a total of 23 patients with an average age of 71.1 years in an open-label, single arm study to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of Alzheimer’s Disease and inflammation that can be measured in cerebral spinal fluid, blood samples, and functional magnetic resonance imaging in patients before and after treatment withc20 mg of NE3107 twice daily for 3 months. The data showed among patients with mild cognitive impairment and mild AD that: NE3107 showed the potential to enhance cognition as measured by multiple assessment tools, reduced CSF phospho-tau levels by -1.66 pg/mL and the ratio of p-tau to A42 by -0.0024, 18 of 22 patients with abnormal baseline scans showed improvement in one or more brain regions as seen from advanced functional MRI studies, no drug-related adverse events were observed. Patients treated with NE3107 for three months showed a reduction of 3.3 years on the Horvath DNA methylation SkinBlood clock. Furthermore, 19 out of the 22 patients experienced this reduction in the SkinBlood clock score. The finding that NE3107 affects the SkinBlood clock provides an impetus to explore further the relationship between NE3107 improving neurodegeneration and other inflammation-driven diseases. The modulation of DNA methylation could enable the up- or down-regulation of specific genes and thus modulate the aging process. Patients treated with NE3107 demonstrated enhanced cognition as evidenced by improvements on multiple assessment scales in this Phase 2 study, and the company’s confirmatory double-blind, randomized controlled study involving subjects who have mild to moderate Alzheimer’s disease is expected to read out in 3Q23.