CARSON CITY, Nev. - BioVie Inc. (NASDAQ: BIVI), a clinical-stage biopharmaceutical company, announced on Tuesday significant findings from its Phase 2a trial of bezisterim for Parkinson's Disease treatment. The trial data indicated that bezisterim, used in conjunction with levodopa/carbidopa, led to substantial improvements in both motor and non-motor symptoms compared to a placebo.
During the XXIX World Congress on Parkinson’s Disease in Lisbon, Portugal, the company presented its findings, which revealed a -2.8 point advantage in the Motor Disease Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III (Motor) score for patients treated with bezisterim versus those on placebo. This improvement was even more pronounced in patients under 70 years old, with a -4.7 point advantage.
Additionally, 30% of patients treated with bezisterim showed improvement in their ability to move before their first morning dose of levodopa/carbidopa, a significant contrast to the placebo group. The findings also noted a -2.4 point improvement in the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) for bezisterim-treated patients, while placebo patients showed worsening symptoms.
The correlation between non-motor and motor symptom improvements suggests bezisterim's potential as an adjunct therapy in Parkinson's Disease, particularly for sleep/fatigue and restlessness in the legs, according to Joseph Palumbo, BioVie’s Chief Medical Officer. The data aligns with previous reports and animal model studies, strengthening the case for bezisterim’s intrinsic and levodopa-enhancing activity.
Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer with anti-inflammatory properties and a low risk of drug-to-drug interaction. It is currently being explored for both Alzheimer’s and Parkinson’s diseases, with Phase 3 trials in Alzheimer’s showing promising results in cognition and biomarker levels improvement.
The company is planning further clinical investigation of bezisterim in late-phase trials. BioVie continues to develop drug therapies for neurological, neurodegenerative, and advanced liver diseases, including its Orphan drug candidate BIV201 for the treatment of ascites due to chronic liver cirrhosis.
The information is based on a press release statement from BioVie Inc.
InvestingPro Insights
As BioVie Inc. (NASDAQ: BIVI) showcases promising trial results for its Parkinson's Disease treatment, investors may be eyeing the financial health and market performance of the company with interest. According to the latest data from InvestingPro, BioVie holds a market capitalization of $29.49 million. Despite the clinical progress, the company's financial metrics reflect some challenges, with an adjusted P/E Ratio for the last twelve months as of Q3 2024 at -0.79, indicating that the company is not currently generating profits relative to its share price. Additionally, the company's price has experienced a notable decline, with a 6-month price total return showing a -90.05% change, underscoring significant volatility in the stock's performance.
InvestingPro Tips suggest that BioVie maintains a stronger liquidity position, as it holds more cash than debt on its balance sheet and its liquid assets exceed short-term obligations. This could provide the company with some financial flexibility as it advances its clinical trials. However, the tips also highlight areas of concern, such as weak gross profit margins and the lack of profitability over the last twelve months, which investors should consider. Furthermore, analysts do not anticipate the company will be profitable this year, and the stock does not pay a dividend to shareholders.
For readers looking for a deeper dive into BioVie's financials and stock performance, there are additional InvestingPro Tips available at: https://www.investing.com/pro/BIVI. To access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are a total of 9 InvestingPro Tips listed for BioVie, offering a comprehensive analysis for informed investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.