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BioVie, Inc. develops clinical-stage drug therapies for neurological and neurodegenerative diseases and advanced liver disease. Company news centers on bezisterim, also known as NE3107, an investigational oral small molecule studied in Parkinson’s disease, Alzheimer’s disease and Long COVID through its effects on neuroinflammation and insulin sensitivity.
Recurring updates include clinical-study enrollment and results planning, scientific-conference abstracts, key opinion leader events and investor presentations. BioVie also reports on BIV201, its orphan drug candidate for refractory ascites associated with liver cirrhosis, alongside corporate communications about pipeline progress and financing activity.
BioVie Inc. (NASDAQ: BIVI) announced its management team's participation in the Oppenheimer 33rd Annual Healthcare Conference, scheduled for March 13-15, 2023. The virtual presentation will take place on March 15, 2023, at 12:40 PM ET, featuring one-on-one investor meetings. BioVie is focused on developing innovative drug therapies for neurological disorders, including Alzheimer's and Parkinson's diseases, and advanced liver disease. Their drug candidate NE3107 is undergoing pivotal trials for Alzheimer's, while BIV201 is in a Phase 2b study for liver cirrhosis. The company aims to improve patient outcomes with its groundbreaking therapies.
BioVie (NASDAQ: BIVI) has announced encouraging preliminary results from its Phase 2 trial of NE3107 for Parkinson's Disease (PD). Six out of 20 patients treated with NE3107 experienced a morning 'on state', compared to none in the placebo group (p=0.02). This state is crucial for PD patients as it indicates optimal motor function. Additionally, NE3107-treated patients showed a significant improvement in motor scores on the Unified Parkinson's Disease Rating Scale compared to those on levodopa alone. The company plans to initiate Phase 3 trials for NE3107, following favorable Phase 2 results.
BioVie Inc. (NASDAQ: BIVI) announced the successful completion of patient enrollment for its NM101 trial, evaluating NE3107 in Alzheimer’s patients, achieving a revised target of 400 patients. The trial is a pivotal Phase 3 study aimed at assessing cognition and function in mild to moderate Alzheimer’s disease patients. Top line results are anticipated in October 2023. The study protocol adapted to increased interest, allowing for enhanced statistical power. Previous Phase 2 results indicated improved cognition with NE3107 treatment. The company aims to address neuroinflammation and insulin resistance related to neurodegenerative diseases.
BioVie (NASDAQ: BIVI) has announced its upcoming BioVie Day on March 23, 2023, at 10 a.m. EST, where it will present a comprehensive overview of recent clinical trial data on its treatments for Alzheimer's, Parkinson's, and liver diseases. This event aims to summarize progress, discuss new clinical trials, and outline plans for regulatory submissions. Notable achievements include the promising Phase 2 results for NE3107 in Alzheimer's and Parkinson's, showing significant cognitive and motor control improvements. Additionally, the liver disease candidate BIV201 holds FDA Fast Track status. More details will be shared as the date approaches.
BioVie Inc. (NASDAQ: BIVI) will be featured in an interview on The RedChip Money Report on Bloomberg TV on December 31, 2022, at 7 p.m. ET. CEO Cuong Do will discuss positive Phase 2 clinical trial data for Alzheimer's and Parkinson's diseases, and plans for potential FDA approval in 2024. BioVie is developing innovative therapies for neurodegenerative disorders and liver disease, with key studies underway for its drug candidates NE3107 and BIV201. The interview will be accessible online and aims to inform investors about the company’s progress.
BioVie Inc. (NASDAQ: BIVI) recently reported significant advancements with its drug candidate NE3107 for treating Parkinson's disease (PD) and Alzheimer's disease (AD). In a trial, PD patients using NE3107 experienced a meaningful increase in motor control after 28 days. Additional data indicated that NE3107 improved cognition in mild cognitive impairment and mild AD patients. Notably, NE3107 reduced biomarkers of aging-related disease by approximately 3.3 years after 3 months of treatment. The company is moving toward Phase 3 trials based on promising results.
BioVie Inc. (NASDAQ: BIVI), a clinical-stage company, announced positive findings from its Phase 2 trial for NE3107, aimed at improving cognitive functions in Alzheimer's patients. The study revealed NE3107 may reduce Horvath DNA methylation SkinBlood clock by 3.3 years after 3 months of treatment. Among 23 patients, results indicated significant cognitive enhancement, with 2.2 point improvement on the modified ADAS-Cog12 scale and a reduction in CSF phospho-tau levels. No adverse events were reported, suggesting NE3107's potential in addressing aging-related diseases.
BioVie Inc. (BIVI) announced positive results from two Phase 2 trials evaluating NE3107 for Parkinson's and Alzheimer's diseases. In the Parkinson's trial, patients receiving NE3107 with levodopa achieved a clinically meaningful improvement of over 3 points in motor function compared to levodopa alone. Notably, those under 70 saw a 6-point enhancement. In the Alzheimer's trial, NE3107 improved cognition, showing a 2.1-point gain on the ADAS-Cog12 scale. Additionally, biomarkers related to neuroinflammation decreased without any adverse effects reported.
BioVie Inc. (BIVI) has increased the enrollment target for its Phase 3 trial evaluating NE3107 in Alzheimer’s patients from 316 to 400 due to rapid recruitment and favorable safety data. Over 316 patients are already enrolled, and the company anticipates completing enrollment in two months, with topline results expected by 3Q2023. The trial aims to assess cognition and functional improvement in patients with mild to moderate Alzheimer's disease. The decision to expand enrollment is based on positive early findings and the absence of serious adverse events.
BioVie Inc. (NASDAQ: BIVI) announced that three abstracts from its Phase 2 study of NE3107 for Alzheimer's Disease were accepted for presentation at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting, scheduled for November 29-December 2, 2022, in San Francisco, CA.
The presentations include:
- Oral: Neuroimaging Data on December 2 at 11:15am PT
- Posters: Biomarker Assessments on December 1 and Clinical Outcomes on November 29-30.
Results will be disclosed post-conference.