BioVie Inc. announced data from an oral presentation made on May 21, 2024 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). Bezisterim-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson?s Disease, whereas placebo patients experienced a worsening of +1.0 points (p=0.0159). Sleep/fatigue domain improvements correlated with motor score improvements (r=0.51; p=0.0259).

More patients on bezisterim had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened. Bezisterim-treated patients experienced an improvement of -0.89 on the urge to move legs/restlessness in legs whereas placebo patients experienced a worsening of +0.99 (p=0.0321).