- The FDA has signed off BioVie Inc's BIVI Phase 2 study assessing NE3107's potential pro-motoric impact in Parkinson's disease patients.
- The NM201 study is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson's disease (PD) participants treated with carbidopa/levodopa and NE3107.
- The Company expects to initiate patient enrollment for the NM201 study before the end of 2021. Topline results are expected by the middle of 2022.
- Forty patients will be randomized to a 1:1 placebo: active 20 mg twice daily for 28 days.
- Safety assessments will look at standard measures of patient health and the potential for drug-drug interactions affecting L-dopa PK and activity.
- The Company has an active Phase 3 trial studying NE3107 in Alzheimer's disease with topline results by the end of 2022.
- Price Action: BIVI shares closed up 21.61% at $6.64 on Tuesday.
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