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BioVie’s Phase 2 Trial Assessing NE3107's Pro-motoric Activity in Parkinson's Disease is Fully Enrolled
Topline Data Expected December 2022 CARSON CITY, Nev., Oct. 19, 2022 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a
About this update from Biovie Inc.
[{"type":"text","content":"Topline Data Expected December 2022\nCARSON CITY, Nev., Oct. 19, 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 that the Company’s Phase 2 trial assessing NE3107’s potential pro-motoric impact in Parkinson’s disease has fully enrolled 44 patients. Topline data readout is expected in December 2022. The NM201 study (NCT05083260) is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson's disease (PD) participants treated with carbidopa/levodopa and NE3107. 44 patients with a defined L-dopa “off state” were randomized 1:1 placebo:active 20 mg twice daily for 28 days. This trial was launched with two design objectives: The primary objective is a drug-drug interaction study as requested by the FDA to demonstrate the absence of adverse interactions of NE3107 with levodopa in humans (no indications of adverse DDI were observed in prior animal studies). Safety assessments will evaluate standard measures of patient health and potential for drug-drug interactions affecting L-dopa PK and activity.The secondary objective is to explore an efficacy signal and determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity in MPTP rodents and nonhuman primates is observed in humans. Efficacy assessments use the Motor Disease Society Unified Parkinson’s Disease Rating (MDS-UPDRS) parts 1-3, ON/OFF Diary, and Non-Motor Symptom Scale. Commenting on the PD trial progress, Cuong Do, BioVie’s President and CEO, said “To date, we have seen no drug-related adverse events in reviews. Additionally, we are detecting what we believe to be an efficacy signal among patients who have completed 28 days of treatment, and we look forward to having the full data from the trial to quantify the full therapeutic impact.” Neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including Alzheimer’s Disease (AD), Parkinson’s Disease (PD), frontotemporal lobar dementia, and ALS. NE3107 is an oral small molecule that is a blood-brain permeable compound with potential anti-inflammatory, insulin sensitizing, and ERK-bindi...