NVG-2089 for CIDP

(INVGOR Trial)

Overseen By Nuvig Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nuvig Therapeutics, Inc.

Must be taking: IVIg, SCIg

Disqualifiers: Diabetes, Guillain-Barre, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, NVG-2089, to assess its safety and effectiveness for people with CIDP, a condition where the immune system attacks the nerves, causing weakness and numbness. NVG-2089 is designed to mimic a protein called IVIg, which can calm the immune system and reduce inflammation. The trial includes two groups: one for individuals who have never received treatments like IVIg, and another for those who have. It may suit individuals with CIDP who have experienced worsening symptoms when their usual treatment was stopped or reduced. 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?

If you are currently on IVIg or SCIg, you will need to stop taking it at least 3 weeks before starting the study drug. The protocol does not specify about other medications, so it's best to discuss with the study team.

Is there any evidence suggesting that NVG-2089 is likely to be safe for humans?

Research has shown that NVG-2089 has been safe in early studies. In one study, healthy volunteers took different doses of NVG-2089, and it remained safe even at higher doses, indicating no major safety issues in the initial testing. The study also found that the drug could be taken every four weeks, offering a convenient and safe dosing schedule. While more research is needed to confirm these results in people with chronic inflammatory demyelinating polyneuropathy (CIDP), this early information provides a good starting point for understanding the safety of NVG-2089. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for CIDP?

Unlike the standard treatments for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which often include corticosteroids, IVIG, and plasmapheresis, NVG-2089 is unique because it targets the underlying disease mechanism directly. Researchers are excited about NVG-2089 because it works by modulating the immune system with a novel mechanism of action. This approach aims to not only alleviate symptoms but also potentially modify the disease course, offering hope for long-term improvement. Additionally, NVG-2089 could provide a more targeted treatment option with fewer side effects compared to current therapies.

What evidence suggests that NVG-2089 might be an effective treatment for CIDP?

Research has shown that NVG-2089 is designed to function like IVIg, a protein that supports the immune system. Early studies demonstrated that NVG-2089 had effects similar to IVIg, reducing inflammation by interacting with certain body parts. This could help treat chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that causes nerve inflammation. Initial findings indicated that NVG-2089 is well tolerated in healthy individuals, with doses administered every four weeks. These results are promising and suggest potential for aiding those with CIDP. Participants in this trial will be divided into two groups: treatment-naive and treatment-experienced, to evaluate the effects of NVG-2089 in different patient populations. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) or Multifocal Motor Neuropathy. Participants should have a confirmed diagnosis and may be experiencing symptoms that affect their daily activities. Specific inclusion and exclusion criteria details are not provided, but typically these would outline health conditions, prior treatments, age range, etc.

Inclusion Criteria

Treatment-naïve participants: No prior treatment with IVIg and/or SCIg and/or corticosteroids and/or investigational therapies for CIDP OR Treatment-experienced participants: On stable dose of IVIg or SCIg with no disease exacerbations for 8 weeks prior to screening. Participants must be willing to discontinue IVIg or SCIg at least 3 weeks (±1 week) prior to dosing with the study drug. Participants on IVIg must be on maintenance dose of 0.4 to 1 g/kg every 2 to 6 weeks per EAN/PNS recommendation. Participants on SCIg should not exceed the dose of 0.4 g/kg per week

My INCAT score fits the trial's requirements for new or previous treatments.

Diagnosed with CIDP or Possible CIDP according to criteria of the EAN/PNS 2021 (Van den Bergh, 2021). Diagnosis to be confirmed by an independent adjudication committee

Exclusion Criteria

My symptoms are not caused by another disease.

I have a history of spinal cord disease or central nervous system damage.

I have not responded well to previous IVIg or SCIg treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NVG-2089 to evaluate safety and efficacy in treating CIDP

14 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NVG-2089

Trial Overview The study tests NVG-2089's safety and effectiveness in patients with CIDP. NVG-2089 is an experimental drug designed to imitate IVIg proteins to reduce inflammation and improve immune system function by targeting specific receptors in the body.

How Is the Trial Designed?

Group I: Treatment Naive Experimental Treatment 1 Intervention

Group II: Treatment Experienced Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nuvig Therapeutics, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07027111

Safety, Tolerability, and Efficacy of NVG-2089 in ... These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior ...

2. nuvigtherapeutics.com nuvigtherapeutics.com/nuvig-therapeutics-announces-first-patient-dosed-in-phase-2-cidp-trial-of-nvg-2089-and-presentation-of-phase-1-data/

NVG-2089 is a recombinant Fc fusion protein ... The first patient has been dosed in its Phase 2 clinical trial evaluating NVG-2089 in individuals with chronic inflammatory demyelinating polyneuropathy (CIDP).

3. rarediseaseadvisor.com rarediseaseadvisor.com/news/phase-1-trial-results-support-development-novel-cidp-treatment/

Phase 1 Trial Results Support the Development of Novel ... NVG-2089 is well tolerated in healthy people at exposures that will allow for dosing intervals of 4 weeks, according to results from a phase 1 clinical trial.

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000208813

A Phase 1 Healthy Volunteer Dose Escalation to Evaluate ... PD responses following treatment with NVG-2089 were similar to that observed in humans following treatment with 1–2g/kg IVIg. These data support ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07027111?cond=Chronic%20inflammatory%20demyelinating%20polyradiculoneuropathy%20OR%20%22chronic%20inflammatory%20demyelinating%20polyneuropathy%22%20OR%20%22%20chronic%20relapsing%20polyneuropathy%22%20OR%20%22%20CIDP%22&aggFilters=status:not%20rec&viewType=Table&rank=9

NCT07027111 | Safety, Tolerability, and Efficacy of NVG- ... The purpose of the study is to evaluate the safety of NVG-2089 and to evaluate how well patients respond to this investigational treatment. NVG-2089 is a new ...