Benzinga | Oct 26, 2021 08:05AM EDT

BioVie Reports FDA Authorization To Initiate Phase 2 Trials Assessing NE3107's Pro-Motoric Activity In Parkinson's Disease

BioVie Inc., (NASDAQ:BIVI) ("BioVie" or the "Company") a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that the FDA has authorized the company to initiate a Phase 2 study assessing NE3107's potential pro-motoric impact in Parkinson's disease patients.

The NM201 study (NCT05083260) is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson's disease (PD) participants treated with carbidopa/levodopa and NE3107. 40 patients with a defined L-dopa "off state" will be randomized 1:1 placebo: active 20 mg twice daily for 28 days. Safety assessments will look at standard measures of patient health and potential for drug-drug interactions affecting L-dopa PK and activity. Efficacy assessments will use the Motor Disease Society Unified Parkinson's Disease Rating (MDS-UPDRS) parts 1-4, Hauser ON/OFF Diary, and Non-Motor Symptom Scale.

Neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including Alzheimer's Disease (AD), Parkinson's Disease (PD), frontotemporal lobar dementia and ALS. NE3107 is an oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK- and NF?B-stimulated inflammation. No major safety signals have been observed in nonclinical and clinical studies conducted to date.

NE3107's potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company's work testing the molecule in AD and PD patients. The company has an active Phase 3 trial studying NE3107 in AD that is expected to have topline results by the end of 2022.

Remarkable parallels exist between AD and PD, among them activated microglia driving inflammation, involvement of TNF?, oxidative stress, mitochondrial dysfunction and insulin resistance. In nonclinical and clinical studies, NE3107 reduced inflammation and enhanced insulin sensitivity, both of which are important to PD pathology. Nonclinical studies in marmoset monkeys have shown NE3107 administered alone to be as pro-motoric as levodopa, underscoring the apparently critical role of inflammation in expression of PD dismobility. When NE3107 was administered with levodopa, the combination improved motor control better than either drug alone. Furthermore, in the marmoset study, NE3107 reduced the severity of levodopa induced dyskinesia (LID) concurrent with pro-motoric benefit and decreased neurodegeneration, preserving twice as many dopaminergic neurons compared to control.

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.