BioVie announces treatment of 1st patient in Phase 2 clinical trial of NE3107,ERK inhibitor that selectively inhibits neuroinflammation

BioVie announces treatment of 1st patient in Phase 2 clinical trial of NE3107 (an ERK inhibitor that selectively inhibits neuroinflammation & insulin resistance) in #Parkinsons

Published: Jan 20, 2022

RENO, Nev., Jan. 20, 2022 (GLOBE NEWSWIRE) -- BioVie, (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders today announced the treatment of the first patient in the Company’s Phase 2 clinical trial assessing the potential pro-motoric impact of its NE3107 asset 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 will be treated with carbidopa/levodopa and NE3107 or placebo. Forty patients with a defined PD medication “off state” will be randomized 1:1 placebo to: active NE3107 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 pharmacokinetics and activity. Exploratory efficacy assessments will use the Motor Disease Society Unified Parkinson’s Disease Rating (MDS-UPDRS) parts 1-3, ON/OFF Diary, and Non-Motor Symptom Scale. Topline results are expected for the NM201 trial in mid-2022.

“Our NM201 study is designed to be an efficient, cost-effective assessment of the safety and pharmacokinetics profile, as well as the potential efficacy of NE3017 for the treatment of PD,” said Cuong V. Do, Chief Executive Officer of BioVie. “Enrollment of the first patient in our human development program is a significant milestone for BioVie, and we look forward to data readout for NM201 in mid-2022.”

In preclinical studies, NE3107 was shown to improve motor symptoms as effectively as L-dopa. When NE3107 was administered in combination with L-dopa, the combination demonstrated greater pro-motoric activity than NE3107 or L-dopa given alone. Furthermore, NE3107 in combination with L-dopa reduced the severity of L-dopa induced dyskinesia (LID) without decreasing the beneficial effect of the drug on motor symptoms. NE3107 treatment in monkeys preserved roughly twice as many dopaminergic neurons as vehicle-treated animals, suggesting that NE3107 may have neuroprotective properties.

Neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including Parkinson’s Disease (PD), Alzheimer’s Disease (AD), frontotemporal dementia and ALS. NE3107 is an oral small molecule, blood-brain permeable, compound with anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK- and NFκB-stimulated inflammation. No major safety signals have been observed in nonclinical safety studies, and the NE3107 adverse event profile has not differed from that of placebo in 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 Alzheimer’s Disease that is expected to have topline results by the end of 2022.

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[Boscoejean]

so for Parkinsons it looks like they are only using this in clinical trials when the person is taking levodopa so why wouldn't they do trials that included individuals who were not yet taking levodopa?

[Ibjcarp in reply to Boscoejean]

Pre trial and phase one trial segments are primarily to ascertain overall safety of the drug. A participant in most P1s are generally in the “not much to lose” category or are in a position where they are willing to accept more personal risk so finding one that was not on C/L would be impossible. As they progress to subsequent stages the trials will become more focused on efficacy once safety is established.

[Boscoejean in reply to Ibjcarp]

I hope so

[Despe]

One more trial to the lengthy list of trials. Another medication to enhance Levodopa!

I am all ears for DISEASE MODIFYING TRIALS. Are there any???

[Cagey84 in reply to Despe]

Hi Despe - see this from Simon last year. There are quite a few of them. content.iospress.com/articl...

[Despe in reply to Cagey84]

Thank you. It is a very lengthy article and have no time or scientific background to interpret it. I hope there will be a disease modifying approach sooner rather than later.

Good luck with all the trials. They should be expedited like COVID19 vaccine. . .

[Cagey84 in reply to Despe]

I understand the time and background point, so it's worth remembering the numbers - 59 out of 142 trials are for disease modifying therapies.

[Despe in reply to Cagey84]

Thank you. May I ask when you were diagnosed and what works best for you?

[Cagey84 in reply to Despe]

2012 - on madopar, rasagiline and amantadine. The madopar and amantadine are very good, rasagiline probably is as well but it’s tough to separate its effect from that of madopar.

[Despe in reply to Cagey84]

Thank you for your response.

Wow, it's been a while since your diagnosis. How are you feeling?

[Cagey84 in reply to Despe]

Pretty good, all things considered. Still mobile, no cognitive issues, just really slow.