- BioVie Inc BIVI announced additional preliminary findings from its Parkinson’s Disease (PD) Phase 2 trial.
- The preliminary findings show that significantly more patients treated with the company’s drug, NE3107, were assessed as being in the “ON” state in the morning after withholding their usual standard of care (SOC) for at least 8 hours before taking their usual morning Parkinson’s medications, compared to patients on SOC alone plus placebo.
- Many PD patients complain of having rigid muscles and difficulties getting out of bed in the morning, which is the muscles being “off state.” Conversely, patients are considered to be in the “on state” if they retain sufficient muscle control.
- “Biovie’s Phase 2 data is encouraging,” commented Dr. Anthony Lang, the Jack Clark Chair for Parkinson’s Disease Research at the University of Toronto, who was not involved with the trial. “Morning “OFF” symptoms cause significant impairment of movement and disability for patients with Parkinson’s Disease.”
- The company previously reported that patients treated with the combination of NE3107 and levodopa experienced a 3+ points improvement on part 3 (motor) score on the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (UPDRS), compared to patients treated with levodopa-alone.
- The preliminary data revealed that 6 out of 20 of the NE3107-treated patients, compared to none of the placebo-treated patients (p=0.02), experienced a morning “on state” with levodopa withheld overnight and before receiving their morning medication.
- Full details from this trial will be presented at the upcoming AD/PD 2023 International Conference on Alzheimer’s and Parkinson’s Diseases.
- The company is preparing to launch the Phase 3 potential pivotal trials to continue developing NE3107 in Parkinson’s Disease.
- Price Action: BIVI shares are up 6.91% at $7.35 on the last check Monday.
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