BioVie and FDA Align on Bezisterim Parkinson’s Trial

BioVie Inc., a clinical-stage company specializing in innovative drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease, has announced significant progress in its upcoming SUNRISE-PD trial focused on Parkinson's disease (PD). The trial will evaluate the effects of bezisterim (NE3107) on both motor and non-motor symptoms in approximately 60 patients who have not previously received carbidopa/levodopa treatment. The company is engaged in trial start-up activities and plans to begin patient screening in the fourth quarter of 2024.

The Food and Drug Administration (FDA) has provided critical feedback on the SUNRISE-PD clinical trial protocol submitted by BioVie. The FDA's sole actionable comment recommended the inclusion of the Part II score from the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) as a primary endpoint for potential registrational filings. Since this metric is already included as a secondary endpoint in the current design, BioVie is able to proceed without making any amendments to the protocol.

Cuong Do, BioVie’s President and CEO, emphasized that the SUNRISE-PD trial aims to enhance the motor experiences of Parkinson’s patients in their daily lives. He highlighted that previous Phase 2a trials showed significant improvements in motor control for patients with moderate to severe Parkinson's symptoms when bezisterim was used in conjunction with levodopa. The upcoming Phase 2 study will investigate bezisterim’s effects on newly diagnosed patients who require medication for the first time, potentially establishing its applicability across the entire Parkinson’s patient population. This could lay the groundwork for a future disease progression study, which is the ultimate objective of the PD program.

The SUNRISE-PD trial will be a Phase 2, multicenter, randomized, double-blind, placebo-controlled study with a hybrid decentralized design. It will span 20 weeks from the initial screening phase to the safety follow-up. During the 12-week double-blind phase, around 60 patients will be randomized to receive either 20 mg of bezisterim (NE3107) or a placebo twice daily. Participants can choose to be involved either entirely from their homes or at a clinical site. At-home participants will be visited by study nurses, and a neurologist will supervise the assessments remotely via video. These assessments will be recorded for review by a central rating committee. If the results are positive, participants may enter a longer-term open-label safety study.

Bezisterim (NE3107) is an orally bioavailable, blood-brain barrier-permeable drug that acts as an insulin sensitizer and anti-inflammatory agent without being immunosuppressive. It has a low risk of drug-to-drug interactions and has shown potential to alleviate symptoms of long COVID, such as fatigue and cognitive dysfunction, by modulating the activation of inflammatory pathways. Bezisterim is also being investigated for Alzheimer’s disease (AD) and Parkinson’s disease (PD). Results from various studies have indicated that bezisterim-treated patients experienced improved cognition and biomarker levels, as well as meaningful improvements in motor control when used in combination with levodopa.

BioVie Inc. is focused on developing innovative drug therapies for neurological and liver diseases. The company’s drug candidate bezisterim inhibits inflammatory activation that leads to neuroinflammation and insulin resistance, both key drivers of AD and PD. In advanced liver disease, the company’s orphan drug candidate BIV201 is being evaluated for the treatment of ascites due to chronic liver cirrhosis, with guidance from the FDA for Phase 3 clinical testing.

BioVie continues to make strides in its research and development efforts, aiming to bring new therapeutic options to patients suffering from debilitating conditions like Parkinson’s and Alzheimer’s disease.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!