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.
“Biovie's Phase 2 data is encouraging,” commented Dr.
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 [1] 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.
“This trial was primarily a safety and drug-drug interaction study that we expanded in hopes of finding an efficacy signal,” explained Cuong Do, BioVie’s President and CEO. “We believe that the data provide a very encouraging efficacy signal as measured by on/off state, and speak to the therapeutic potential we believe NE3107 may have for the treatment of PD.”
Full details from this trial will be presented at the upcoming AD/PD™ 2023
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.
About BioVie
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This press release contains forward-looking statements, including statements regarding the Company’s strategy, plans and objectives, such as statements regarding the Company’s anticipated timeline for announcing results from the NE3107 Phase 2 trial and details regarding the launch of its Phase 3 potential pivotal trials. Forward-looking statements may generally be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although
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[1] Horvath K. doi.org/10.1016/j.parkreldis.2015.10.006
Day 28 Improvement in Motor Controls vs. Day 0
Day 28 Improvement in Motor Controls vs. Day 0
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