BioVie’s Bezisterim Demonstrates Potential Improvements in Sleep/Fatigue and Restless Leg Symptoms for Parkinson’s Disease Patients

Full Dataset from Phase 2a trial in Parkinson’s Disease suggest patients treated with bezisterim experienced significant improvements in both non-motor symptoms and motor control while placebo-treated patients worsened

Improvements in non-motor symptoms correlated with improvements
in motor symptoms for Parkinson’s Disease patients

CARSON CITY, Nev., May 22, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced data from an oral presentation made yesterday at the XXIX World Congress on Parkinson’s Disease and Related Disorders hosted by the International Association of Parkinsonism and Related Disorders (IAPRD) and held May 19-22, 2024 in Lisbon, Portugal.

The presentation 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, and suggest improvements of bezisterim-treated patients with non-motor symptoms. These full dataset findings complement previously reported topline dataset findings of improvement in motor symptoms in patients treated with bezisterim and demonstrate potential intrinsic, levodopa-enhancing activity of bezisterim that is consistent with data from animal models.

Patients treated with bezisterim and levodopa/carbidopa experienced a -2.8 point advantage on the Patr III (Motor) score on the Motor Disease Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) compared to patients treated with placebo and levodopa/carbidopa. In patients younger than 70 years old (~50% of patients), the advantage for bezisterim-treated patients was -4.7 points. Furthermore, 30% of bezisterim-treated patients experienced improvement in their ability to move, having Part 3 scores prior to their first morning dose of carbidopa/levodopa that were equal to or better than Part 3 scores associated with their being in the “on” state after carbidopa/levodopa treatment at the start of the study, whereas none of the placebo patients had the similarly improved morning Part 3 scores. The difference was statistically significant (p=0.02).