BioVie Inc. 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 (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. The Company previously reported that patients treated with the combination of NE3107 and levodopa experienced a 3+ points improvement on the part 3 (motor) score on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (UPDRS), compared to patients treated with levodopa-alone. This difference is considered to be clinically meaningful according to PD experts.

The difference is 6+ points among patients younger than 70 years old who presumably have less disease progression. Before study commencement and at multiple points throughout the 28-day trial, patients who did not receive PD medications for at least 8 hours overnight were observed using UPDRS first thing in morning (hour 0). Patients were then given medication and observed again using UPDRS at 1, 2, 3, 4, and 8 hours after drug administration.

Part 3 of the UPDRS instrument assessed motor control. 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. This is explained by and can be seen most visibly from the right panel of the chart showing that NE3107-treated patients had lower part 3 (motor) disease score at time 0 (before medication administration) compared to those treated with levodopa alone.

These exploratory findings in human subjects are consistent with earlier findings from non-human primates, which demonstrated the intrinsic promotoric activity of NE3107. 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. The NM201 study (NCT05083260) was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson's disease (PD) participants treated with carbidopa/levodopa and NE3107. 45 patients were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days.

This trial was launched with two design objectives: 1) the primary objectives were safety and a drug-drug interaction study as requested by the FDA to demonstrate the absence of adverse interactions of NE3107 with levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity can be seen in humans.