NE3107 for Parkinson's Disease

(SUNRISE-PD Trial)

Recruiting at 44 trial locations

Overseen By Ryan Drake, DO

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioVie Inc.

Must not be taking: Levodopa

Disqualifiers: Major mental, physical illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new treatment, bezisterim (also known as NE3107), can reduce movement symptoms in people with Parkinson's disease. Participants will take either bezisterim or a placebo (a look-alike pill with no active drug) to assess the treatment's effectiveness. The trial is open to those diagnosed with Parkinson's within the last 18 months who haven't started specific treatments like levodopa. Participants should be in generally good health and nearing the need for symptom relief. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken levodopa or similar drugs for Parkinson's symptoms before joining.

Is there any evidence suggesting that NE3107 is likely to be safe for humans?

A previous study administered NE3107 to individuals with Parkinson's disease to assess its safety and efficacy. Researchers found that NE3107 was generally well-tolerated, with most participants not experiencing serious side effects. Another study tested NE3107 in individuals already taking other Parkinson's medications and found similar results, with no major safety issues.

These findings suggest that NE3107 is likely safe for humans. However, these studies were short-term. The upcoming trial will help determine if NE3107 remains safe with long-term use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

NE3107 is unique because it targets inflammation and insulin resistance, both of which are believed to play roles in the progression of Parkinson's Disease. Most treatments for Parkinson's, like Levodopa, primarily focus on managing symptoms by increasing dopamine levels in the brain. However, NE3107 works differently by potentially slowing disease progression through its anti-inflammatory effects. Researchers are excited about NE3107 because it offers a novel approach that might address underlying disease mechanisms, not just the symptoms.

What evidence suggests that NE3107 might be an effective treatment for Parkinson's disease?

Research has shown that NE3107, which participants in this trial may receive, may help alleviate Parkinson's disease symptoms. For patients already taking levodopa/carbidopa, NE3107 has demonstrated potential benefits. Specifically, individuals with Parkinson's who used NE3107 experienced improvements in non-motor symptoms, such as better sleep and reduced fatigue, with a significant improvement of -2.4 points. Although NE3107 has also been tested for Alzheimer's, its positive effects on Parkinson's, particularly for non-motor symptoms, are promising. These findings suggest NE3107 could enhance the quality of life for those with early Parkinson's disease. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people aged 45-80 with early Parkinson's who are close to needing symptom relief but haven't started treatment like levodopa. They must be in good health, agree to birth control, consent voluntarily, and allow DNA analysis from blood samples. Only those diagnosed within the last 18 months can join.

Inclusion Criteria

Do you have moderate difficulty with at least two of the following: walking, using your hands, speaking clearly, or facial expression?

Exclusion Criteria

Do you currently have noticeable problems with balance or have you fallen due to balance issues in the past month?

Have you taken or are you currently taking Levodopa?

Have you taken or are you currently taking Miraplx (Pramipexole)?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants take bezisterim or placebo twice daily for four months

16 weeks

7 visits (in-person or at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NE3107

Trial Overview The study tests NE3107 against a placebo to see if it reduces movement symptoms in Parkinson's patients. Participants will take the drug or placebo twice daily for four months and attend seven visits over five months for physical exams including an ECG.

How Is the Trial Designed?

Group I: NE3107 Experimental Treatment 1 Intervention

Subjects will receive 20 mg NE3107 BID (twice daily administration; 40 mg daily) as oral capsules.

Group II: Placebo Placebo Group 1 Intervention

Subjects will receive matching placebo capsules for oral administration BID (twice daily).

Who Is Running the Clinical Trial?

BioVie Inc.

Lead Sponsor

Trials

8

Recruited

800+

Published Research Related to This Trial

In a study involving 16 patients with moderate Parkinson's disease, the NR2B-selective NMDA receptor antagonist MK-0657 did not show significant improvement in motor function compared to placebo, despite achieving the target plasma concentration.

While MK-0657 was generally well tolerated, it did lead to increases in blood pressure, indicating potential safety concerns that may limit its use in treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose administration of MK-0657, an NR2B-selective NMDA antagonist, does not result in clinically meaningful improvement in motor function in patients with moderate Parkinson's disease. Addy, C., Assaid, C., Hreniuk, D., et al.[2013]

Long-term levodopa therapy for Parkinson's disease can lead to late motor complications due to its rapid action and competition with amino acids, which may be exacerbated by disease progression.

Cabergoline, a long-acting dopamine D2 receptor agonist, shows promise as an alternative to levodopa, with initial studies indicating comparable efficacy and potential to reduce late motor complications through steady receptor stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacodynamic and pharmacokinetic features of cabergoline. Rationale for use in Parkinson's disease. Fariello, RG.[2018]

In a study involving eight parkinsonian monkeys, co-administration of the NMDA receptor antagonist CI-1041 with L-dopa significantly reduced the development of L-dopa-induced dyskinesias (LID), with only one monkey showing mild symptoms compared to all four in the L-dopa alone group.

The effectiveness of L-dopa in alleviating Parkinson's symptoms remained similar in both treatment groups, indicating that CI-1041 can potentially manage LID without compromising the therapeutic benefits of L-dopa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a selective glutamate antagonist on L-dopa-induced dyskinesias in drug-naive parkinsonian monkeys. Hadj Tahar, A., Grégoire, L., Darré, A., et al.[2014]

In a phase 2 study involving 71 patients with Parkinson's disease and levodopa-induced dyskinesia, the nicotinic acetylcholine receptor α7 agonist AQW051 did not show significant improvements in reducing dyskinesia or overall Parkinson's symptoms after 28 days of treatment.

AQW051 was well tolerated by participants, with common side effects including dyskinesia, fatigue, nausea, and falls, indicating that while it may not be effective, it does not pose major safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Trenkwalder, C., Berg, D., Rascol, O., et al.[2019]

In a study involving 22 Parkinson's disease patients, a single dose of the NR2B antagonist MK-0657 (7 mg) did not significantly reduce levodopa-induced dyskinesias or improve motor symptoms, indicating it may not be an effective treatment for these issues.

Despite achieving the target plasma concentration of the drug, MK-0657 showed no meaningful impact on dyskinesia or motor function as measured by established scales, suggesting that further research is needed to explore effective treatments for levodopa-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase Ib Randomized Controlled Study to Evaluate the Effectiveness of a Single-Dose of the NR2B Selective N-Methyl-D-Aspartate Antagonist MK-0657 on Levodopa-Induced Dyskinesias and Motor Symptoms in Patients With Parkinson Disease. Herring, WJ., Assaid, C., Budd, K., et al.[2018]

A new drug has demonstrated potential in delaying the onset of Parkinsonism, which is a significant advancement for patients at risk of developing this condition.

The findings suggest that this drug could improve the quality of life for individuals by postponing the debilitating symptoms associated with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delaying the onset of parkinson's disease. [2016]

In a study involving 80 participants, those treated with acupuncture combined with madopar showed a 92% effective rate in alleviating motor disorders due to Parkinson's disease, significantly higher than the control group that received madopar alone.

The results suggest that acupuncture not only enhances the effectiveness of madopar but may also allow for a reduced dosage of the medication needed for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fifty cases of Parkinson's disease treated by acupuncture combined with madopar. Ren, XM.[2019]

Deep brain stimulation (DBS) is effective for treating motor symptoms of Parkinson's disease, particularly when targeting the subthalamic nucleus and globus pallidus internus, which consistently improve motor features.

While some non-motor symptoms also show improvement with DBS, further research is needed to understand these effects better and to explore other deep brain targets like the pedunculopontine nucleus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Fasano, A., Daniele, A., Albanese, A.[2022]

Despite extensive research and numerous clinical trials since the 1980s, no treatment has been proven to effectively halt or slow the progression of Parkinson's disease, highlighting the challenges in translating laboratory findings into effective therapies.

Various classes of compounds, including monoamine oxidase-B inhibitors and dopaminergic drugs, have been tested, but the search for effective neuroprotective treatments continues, with emerging strategies like gene therapy showing potential for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection against Parkinson's disease progression: clinical experience. LeWitt, PA., Taylor, DC.[2021]

In a study involving 65 Parkinson's disease patients, the oral formulation NC001 significantly reduced falls and freezing of gait (FOG) compared to placebo, indicating its potential efficacy in managing these challenging symptoms.

NC001 was found to be safe and well-tolerated, with a notable improvement in ambulation as measured by the Unified Dyskinesia Rating Scale, suggesting that it effectively stimulates nicotinic receptors to alleviate certain motor symptoms in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine Bitartrate Reduces Falls and Freezing of Gait in Parkinson Disease: A Reanalysis. Lieberman, A., Lockhart, TE., Olson, MC., et al.[2020]

Citations

1. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/NE3107_UPDATE_2_%28drug_in_development%29.pdf

NE3107 (HE3286) NE3107 treatment did not significantly improve cognitive and functional scores in AD patients in a phase. 3 study that was underpowered; only a subset of ...

2. investors.bioviepharma.com investors.bioviepharma.com/news/news-details/2023/BioVie-Announces-Efficacy-Data-from-Phase-3-Trial-of-NE3107-in-Patients-with-Mild-to-Moderate-Alzheimers-Disease-11-29-2023/default.aspx

BioVie Announces Efficacy Data from Phase 3 Trial of ... Patients treated with NE3107 showed improved performance compared to placebo on all cognitive and functional assessments commonly used in the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06757010

NCT06757010 | A Study of NE3107 in Early Parkinson's The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000202435

Safety, Tolerability, And Efficacy Of NE3107 From A Phase ... This study aimed to demonstrate the potential therapeutic benefits of NE3107 in levodopa/carbidopa-treated patients with PD.

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/biovie-report-win-parkinsons-alzheimers-candidate/

BioVie report another win with Alzheimer's and Parkinson's ... The data showed that NE3107 patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the non-motor symptom ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05083260

NE3107 Activity and Safety in Patients With Parkinson's ... A 28-day phase 2a, double-blind, placebo-controlled (1:1), multi-center study of 20 mg NE3107, twice daily of safety, potential drug-drug interactions, and MDS ...

7. investors.bioviepharma.com investors.bioviepharma.com/news/news-details/2023/BioVie-Presents-Data-for-NE3107-at-2023-International-Congress-of-Parkinsons-Disease-and-Movement-Disorders-08-28-2023/default.aspx

BioVie Presents Data for NE3107 at 2023 International ... Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker ...

8. cndlifesciences.com cndlifesciences.com/bezisterim-phase-2-trial/

Bezisterim Moves to Phase 2 Trial for Parkinson's Disease It has fully funded a Phase 2 clinical trial of bezisterim (NE3107) to assess the molecule in the treatment of early Parkinson's disease (PD).