BioVie to Unveil Phase 2 Bezisterim Trial Design for Early Parkinson's at 2024 ATMRD Congress

June 20, 2024-- BioVie Inc., (NASDAQ: BIVI), a clinical-stage company focused on creating innovative drug therapies for neurological and neurodegenerative disorders as well as advanced liver disease, has announced its participation in the Advanced Therapeutics in Movement and Related Disorders Congress® (ATMRD Congress). This event is scheduled to take place from June 21-25, 2024, in Washington, D.C.

BioVie will be presenting two posters at the congress. The first presentation, titled "Assessment of Bezisterim (NE3107) in Patients with Early Parkinson’s Disease: A Phase 2, Placebo-Controlled Study," will discuss the methodology for their upcoming Phase 2 trial. This trial aims to assess the efficacy of bezisterim in patients with Parkinson’s disease who have not yet been treated with carbidopa/levodopa but require symptomatic relief for motor symptoms. This poster will be displayed during Poster Presentation Session B on June 22 from 5-5:30 p.m. EDT.

The second presentation, "Improvement of Motor and Non-Motor Symptoms with Bezisterim (NE3107) Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2a, Placebo-Controlled Study," will present data on the effects of bezisterim when used alongside carbidopa/levodopa. It will highlight the potential benefits of bezisterim on both motor and non-motor symptoms in Parkinson’s disease patients. This poster will be available during Poster Presentation Session A on June 22 from 4:20-4:50 p.m. EDT.

Both posters will be exhibited for the duration of the congress, and further details on the data and findings will be shared subsequently.

Bezisterim (NE3107) is an orally administered, blood-brain barrier-permeable insulin sensitizer that also has anti-inflammatory properties without being immunosuppressive. It has a low risk of drug-to-drug interactions and is currently being researched for its potential to alleviate symptoms of long COVID, such as fatigue and cognitive dysfunction. The drug works by modulating the activation of NFkB, which is believed to play a role in the body's inflammatory response.

BioVie is also exploring bezisterim's potential in treating Alzheimer's disease (AD) and Parkinson's disease (PD). Previous studies have shown promising results. A Phase 3 study (NCT04669028) for Alzheimer's disease demonstrated efficacy in patients with mild to moderate AD. Results were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022, showing improved cognition and biomarker levels among bezisterim-treated patients. In Parkinson’s disease, a Phase 2 study (NCT05083260) revealed that bezisterim, when used in combination with levodopa, led to significant improvements in motor control and "morning on" symptoms without any drug-related adverse events. These findings were presented at the AD/PD™ 2023 International Conference in Gothenburg, Sweden.

BioVie Inc. is a clinical-stage company dedicated to developing new drug therapies for treating neurological and neurodegenerative disorders and advanced liver disease. The company's lead drug candidate, bezisterim, targets inflammatory processes and insulin resistance, key factors in the progression of Alzheimer's and Parkinson's diseases. Additionally, BioVie is progressing with BIV201, an Orphan drug candidate for treating ascites due to chronic liver cirrhosis, which has received Fast Track status from the U.S. Food and Drug Administration (FDA). The active ingredient in BIV201 is approved in about 40 countries for related complications of advanced liver cirrhosis.

BioVie’s commitment to advancing medical science is reflected in its rigorous clinical trials and ongoing research aimed at bringing effective treatments to patients suffering from debilitating diseases.

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