BioVie’s Phase 2 trial evaluating the motor-promoting activity of NE3107 in Parkinson’s disease is fully enrolled

Main data expected in December 2022

CARSON CITY, Nev., Oct. 19, 2022 (GLOBE NEWSWIRE) — 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 trial The Company’s Phase 2 trial evaluating potential pro-motor impact in Parkinson’s disease has fully enrolled 44 patients. The reading of the Topline data is expected in December 2022.

Study NM201 (NCT05083260) is a double-blind, placebo-controlled study of safety, tolerability, and pharmacokinetics in participants with Parkinson’s disease (PD) treated with carbidopa/levodopa and NE3107. 44 patients with a defined “off state” of L-dopa were randomized 1:1 placebo: active 20 mg twice daily for 28 days. This trial was initiated with two design objectives:

  1. The main objective is a drug interaction study requested by the FDA to demonstrate the absence of adverse interactions of NE3107 with levodopa in humans (no indication of adverse DDI was observed in previous studies on the animals). Safety evaluations will assess standard measures of patient health and the potential for drug interactions affecting the pharmacokinetics and activity of L-dopa.
  2. The secondary objective is to explore an efficacy signal and to determine if preclinical indications of promoter activity and apparent enhancement of levodopa activity in MPTP rodents and non-human primates are observed in the man. Efficacy ratings use the Motor Disease Society Unified Parkinson’s Disease Rating (MDS-UPDRS) Parts 1-3, ON/OFF Diary, and Non-Motor Symptom Scale.

Commenting on the progress of the PD trial, Cuong Do, President and CEO of BioVie, said, “To date, we have not seen any drug-related adverse events in the reviews. Additionally, we are detecting what we believe is a signal of efficacy in patients who have completed 28 days of treatment, and we look forward to having full trial data to quantify the total therapeutic impact.

Neuroinflammation, insulin resistance and oxidative stress are common features of major neurodegenerative diseases including Alzheimer’s disease (AD), Parkinson’s disease (PD), frontotemporal lobar dementia and ALS. NE3107 is an oral small molecule that is a blood- and brain-permeable compound with potential anti-inflammatory, insulin-sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK and NFκB-stimulated inflammation. The potential of NE3107 to inhibit neuroinflammation and insulin resistance forms the basis of the Company’s work to test the molecule in patients with AD and PD. The company recently provided early data from an exploratory Phase 2 biomarker trial studying NE3107 in AD and has an active Phase 3 trial in AD that is expected to have breakthrough results by mid- 2023.

Remarkable parallels exist between AD and PD, among them activated microglia leading to inflammation, TNFα involvement, oxidative stress, mitochondrial dysfunction and insulin resistance. In non-clinical and clinical studies, NE3107 reduced inflammation and improved insulin sensitivity, both important for PD pathology. Non-clinical studies in marmoset monkeys showed that NE3107 administered alone was as pro-motive as levodopa, highlighting the apparently critical role of inflammation in the expression of PD immobility. When NE3107 was given with levodopa, the combination improved motor control better than either drug alone. Additionally, in the marmoset study, NE3107 reduced the severity of levodopa-induced dyskinesia (LID) concurrently with pro-motor benefits and decreased neurodegeneration, preserving twice as many dopaminergic neurons per report to the witness.

About BioVie

BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative therapies to overcome unmet medical needs in chronic debilitating diseases. In neurodegenerative diseases, the Company’s drug candidate NE3107 inhibits inflammatory activation of ERK and NFkB (eg, TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions ( for example, insulin signaling and neuron growth and survival). Both are at the origin of Alzheimer’s and Parkinson’s diseases. The Company is Conducting a Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Potentially Pivotal Study to Evaluate NE3107 in Patients with Mild to Moderate Alzheimer’s Disease (NCT04669028) and Aims for Completion from primary to mid-2023. It is estimated that six million Americans suffer from Alzheimer’s disease. A phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) is fully enrolled and is expected to have a first-line data readout in December 2022. In liver disease, the company’s orphan drug candidate BIV201 (terlipressin in continuous infusion), with FDA Fast Track status, is being evaluated in a US Phase 2b study for the treatment of refractory ascites due to cirrhosis of the liver, with first results expected in mid-2023. BIV201 is delivered as a patent-pending liquid formulation. The active agent is approved in approximately 40 countries for complications of advanced liver cirrhosis, but is not available in the United States or Japan. For more information, visit http://www.bioviepharma.com/.

Forward-looking statements

This press release contains forward-looking statements, which can be identified by words such as “expect”, “look forward to”, “anticipate”, “intend”, “plan”, “believe”. , “seek”, “estimate”, “will”, “project” or words of similar meaning. Although BioVie Inc. believes that these forward-looking statements are based on reasonable assumptions, it cannot guarantee that its expectations will be achieved. Actual results may differ materially from those expressed or implied by the statements above due to the Company’s ability to successfully raise sufficient capital on reasonable terms or at all, available liquidity and contractual limitations. and statutory which could adversely affect our ability to pay future dividends, our ability to complete our preclinical or clinical studies and obtain approval of our product candidates, to successfully defend possible future litigation, changes in the terms local or national economic as well as various additional risks, many of which are now unknown and generally beyond the control of the Company, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q , reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. assumes no obligation to update the statements contained herein (including forward-looking statements), except as required by law.

For investor relations inquiries:

Contact:
Bruce Mackle
General director
LifeSci Advisors, LLC
[email protected]


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