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BioVie Announces Additional Findings from Phase 2 Alzheimer’s Disease Trial: NE3107 Appears to Impact Biomarkers of Aging-Related Disease States in Addition to Observed Reversal of Cognitive Decline in Dementia
Initial Data shows NE3107 may Reduce Horvath DNA Methylation SkinBlood Clock by 3.3 years after 3 months of treatment CARSON CITY, Nev., Dec. 06, 2022 (GLOBE
About this update from Biovie Inc.
[{"type":"text","content":"Initial Data shows NE3107 may Reduce Horvath DNA Methylation SkinBlood Clock by 3.3 years after 3 months of treatment\nCARSON CITY, Nev., Dec. 06, 2022 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced encouraging data suggesting that NE3107 has an impact on improving patients’ DNA methylation profiles, potentially impacting biomakers of aging-related disease states. The Phase 2 Investigator-Sponsored Trial (NCT05227820) 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 (AD) and inflammation that can be measured in cerebral spinal fluid, blood samples, and functional magnetic resonance imaging in patients before and after treatment with 20 mg of NE3107 twice daily for 3 months. Dr. Sheldon Jordan (the Principal Investigator) and his team presented detailed data through posters and a platform presentation at the Clinical Trial in Alzheimer’s Disease (CTAD) annual conference, held in San Francisco, CA that ended December 2, 2022. These data showed the following among patients with MMSE>=20 (i.e., mild cognitive impairment and mild AD): NE3107 showed the potential to enhance cognition as measured by multiple assessment tools, including a 2.2 point improvement (p=0.0173) on the modified ADAS-Cog12 scale equating to a 21.1% (p=0.0079) change compared to baseline, a 0.11 point improvement (p=0.0416) on the Clinical Dementia Rating scale (CDR), equating to 19.4% (p=0.0416) change from baseline, and a 0.07 point improvement in the ADCOMS scale, equating to 27.4% improvement (p=0.009).NE3107 reduced CSF phospho-tau levels by -1.66 pg/mL (p=0.0343) and the ratio of p-tau to A42 by -0.0024 (p=0.0401)18 of 22 patients with abnormal baseline scans showed improvement in one or more brain regions as seen from advanced functional MRI studiesNo drug-related adverse events were observed NE3107’s Potential Impact on Biomakers of Aging-related Disease States Blood samples were taken from the patients who participated in the Alzheimer’s Phase 2 trial before and after 3 months of treat...