BIVI - BioVie reports encouraging data from mid-stage Parkinson's Disease trial

2023-03-06 09:17:30 ET

• BioVie ( NASDAQ: BIVI ) announces additional preliminary findings from its Parkinson’s Disease (PD) Phase 2 trial.
• The 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 (p<0.02).
• Many PD patients complain of having rigid muscles and difficulties getting out of bed in the morning, which is referred to as the muscles being in an “off state.” Conversely, patients are considered to be in the “on state” if they retain sufficient muscle control.
• The “on state” is clinically meaningful for PD patients because it is the time when their motor symptoms are most optimally controlled, allowing for better movement and stability.
• Additional per protocol analysis of 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 prior to 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 to be held March 28-April 1, 2023 in Gothenburg, Sweden.
• Based on the favorable results from the Phase 2 trial, the Company is currently preparing to launch the Phase 3 potential pivotal trials to continue developing NE3107 in Parkinson’s Disease. The Company expects to disclose additional details in the near future.

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