BioVie’s Bezisterim Shows Promise for Parkinson’s Sleep, Fatigue, and Restless Leg Symptoms

BioVie Inc., a clinical-stage company noted for its innovative drug therapies for neurological and neurodegenerative disorders, has unveiled significant data from a Phase 2a trial investigating bezisterim for treating Parkinson’s Disease. Presented at the XXIX World Congress on Parkinson’s Disease and Related Disorders in Lisbon, Portugal, the findings highlight the potential of bezisterim in enhancing both motor and non-motor symptoms in Parkinson’s patients compared to those who received a placebo.

The study, titled "Improvement of Motor and Non-Motor Symptoms with Bezisterim Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2A, Placebo-Controlled Study," was presented on May 21, 2024. Results indicated that patients treated with bezisterim alongside levodopa/carbidopa demonstrated notable improvements in non-motor symptoms. This adds to previous findings that bezisterim markedly enhances motor symptoms, suggesting that the drug may potentiate the effects of levodopa, a common treatment for Parkinson’s Disease.

Data showed that bezisterim-treated patients had a -2.8 point advantage on the Part III (Motor) score of the Motor Disease Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) compared to those on placebo. This improvement was even more pronounced in patients under the age of 70, with a -4.7 point advantage. Furthermore, 30% of bezisterim-treated patients showed improved mobility, achieving motor scores after their first morning dose that were as good or better than their scores after being treated with carbidopa/levodopa at the study's start. In contrast, no such improvement was observed in the placebo group, a difference that was statistically significant (p=0.02).

In terms of non-motor symptoms, bezisterim-treated patients experienced a significant improvement of -2.4 points in the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) for Parkinson’s Disease, while placebo patients' symptoms worsened by +1.0 points (p=0.0159). Improvements in the sleep/fatigue domain were closely correlated with enhancements in motor scores (r=0.51; p=0.0259). Additionally, bezisterim-treated patients also showed better outcomes in the NMSS domain for restlessness in legs, improving by -0.89 points compared to a +0.99 point worsening in the placebo group (p=0.0321).

Dr. Joseph Palumbo, BioVie’s Chief Medical Officer, emphasized that these findings suggest bezisterim may effectively address specific non-motor symptoms in Parkinson’s Disease, particularly regarding sleep/fatigue and leg restlessness. He noted that the improvements in motor symptoms previously reported are consistent with these new findings and support the potential of bezisterim for further clinical trials in later stages.

Bezisterim (NE3107) is an orally bioavailable, blood-brain barrier-permeable insulin sensitizer with anti-inflammatory properties. It does not suppress the immune system and has a low risk of drug interactions. Beyond Parkinson’s, bezisterim is being explored for treating Alzheimer’s Disease. Preliminary results from various trials, including a Phase 3 study for Alzheimer’s and a Phase 2 study for Parkinson’s, have shown promising outcomes, including improved cognition and motor control in respective patient groups.

BioVie Inc. continues to focus on developing treatments for neurological degenerative diseases and advanced liver disease. The company's drug candidate bezisterim works by inhibiting inflammatory pathways, potentially addressing both Alzheimer’s and Parkinson’s diseases. Additionally, BioVie is advancing its Orphan drug candidate BIV201 for liver disease, which is currently being evaluated for Phase 3 clinical testing with the FDA's guidance.