#1 Clinical Trials Search in Europe

NVG-2089

NVG-2089 is an investigational drug currently being studied in clinical trials for patients with immune-related disorders, specifically Immune Thrombocytopenia (ITP) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This novel treatment is designed to mimic the effects of a protein called IVIg by binding to specific receptors in the body, activating them to reduce inflammation and support immune system function. The ongoing clinical trials aim to evaluate the safety, tolerability, and efficacy of NVG-2089 in patients suffering from these challenging conditions. This article provides an overview of the current clinical trials and what they might mean for patients with these disorders.

Table of Contents

What is NVG-2089?

NVG-2089 is an investigational medication currently being developed for treating autoimmune conditions[1][2]. It is a new drug that is designed to mimic the effects of a protein called IVIg (Intravenous Immunoglobulin). IVIg is a treatment made from antibodies collected from thousands of blood donors and is currently used to treat various autoimmune and inflammatory conditions.

How NVG-2089 Works

NVG-2089 works by attaching (binding) to certain receptors in the body and activating them. This mechanism helps to[1][2]:

  • Reduce inflammation – Inflammation is the body’s response to injury or infection but can be harmful when the immune system mistakenly attacks healthy tissues.
  • Support immune system function – By modulating how the immune system works, NVG-2089 may help correct abnormal immune responses seen in autoimmune conditions.

Unlike traditional IVIg that requires donations from many blood donors, NVG-2089 is specifically designed as a manufactured alternative that targets the same biological pathways[1][2].

Conditions Treated with NVG-2089

Based on current clinical trials, NVG-2089 is being investigated for the treatment of two main autoimmune conditions[1][2]:

  • Immune Thrombocytopenia (ITP) – A condition where the immune system mistakenly attacks and destroys platelets (blood cells that help with clotting).
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – A rare neurological disorder where the immune system attacks the protective covering of nerves.

NVG-2089 for Immune Thrombocytopenia (ITP)

Immune Thrombocytopenia (ITP) is a condition where your immune system mistakenly attacks and destroys platelets in your blood. Platelets are cell fragments that help your blood clot when you’re injured. When you have ITP, you may bruise easily and be at higher risk for bleeding because you have fewer platelets[1].

NVG-2089 is being studied in patients with ITP to see if it can increase platelet counts to safer levels. The clinical trial for ITP is evaluating how well patients respond to the treatment based on increases in platelet counts[1].

Researchers consider the treatment successful if[1]:

  • For patients starting with platelet counts between 20,000 to 30,000 cells/mm³: Success means either doubling their platelet count or reaching at least 50,000 cells/mm³. A normal platelet count is typically between 150,000 to 450,000 cells/mm³.
  • For patients starting with platelet counts between 30,000 to 50,000 cells/mm³: Success means either doubling their platelet count or reaching at least 80,000 cells/mm³.
  • For all patients: An increase of at least 20,000 cells/mm³ from where they started is also considered a positive response.

NVG-2089 for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a rare neurological disorder where the immune system attacks the protective covering (myelin) of nerves outside the brain and spinal cord. This damage leads to weakness, numbness, and tingling in the arms and legs[2].

The clinical trial for CIDP includes two groups of participants[2]:

  1. Treatment-naïve participants – These are patients who have not received previous treatment for CIDP.
  2. Treatment-experienced participants – These are patients who have previously received treatments for CIDP.

Success of the treatment is measured differently for each group[2]:

  • For treatment-naïve participants: The goal is to see clinical improvement by Week 14, measured by:
    • Improvement of 1 point on the adjusted INCAT score (a scale that measures disability in CIDP)
    • OR improvement of 4 points on I-RODS (a scale that measures overall disability)
    • OR improvement of 8 kilopascals (kPa) in mean grip strength of the dominant hand
  • For treatment-experienced participants: Success is determined if any of the following occur:
    • Achieving clinical improvement as defined above
    • No worsening in adjusted INCAT score between Weeks 4 and 14
    • Initial worsening followed by return to baseline condition and maintenance through Week 14

Current Clinical Studies

NVG-2089 is currently being studied in clinical trials to assess its safety, tolerability, and effectiveness. Two main studies are ongoing[1][2]:

  1. Study for ITP (NCT07095127): An open-label, intra-participant dose escalation study to evaluate NVG-2089 in patients with Immune Thrombocytopenia. The study follows participants for 85 days to evaluate safety and effectiveness[1].
  2. Study for CIDP (NCT07027111): A Phase 2, open-label study to evaluate NVG-2089 in patients with Chronic Inflammatory Demyelinating Polyneuropathy. This study follows participants for 14 weeks to assess safety and efficacy[2].

“Open-label” means that both the researchers and participants know which treatment is being administered. This differs from “blinded” studies where participants don’t know which treatment they’re receiving[1][2].

Safety Information

As with any investigational treatment, safety is a primary concern. Both clinical trials for NVG-2089 are designed to carefully monitor[1][2]:

  • Treatment-Emergent Adverse Events (TEAEs) – These are any unfavorable medical occurrences that develop or worsen after starting the treatment.
  • Serious Adverse Events (SAEs) – These are adverse events that result in hospitalization, disability, or are life-threatening.

The safety monitoring period extends throughout the entire treatment period and follow-up. For the ITP study, this is 85 days[1], while the CIDP study monitors participants through 14 weeks of treatment[2].

It’s important to note that as an investigational drug, NVG-2089 is not yet approved by regulatory agencies like the FDA, and the full safety profile is still being established through these clinical trials[1][2].

Aspect ITP Trial (NCT07095127) CIDP Trial (NCT07027111)
Trial Design Open-label, intra-participant dose escalation study Phase 2, open-label study
Primary Outcomes Safety: Incidence, nature, and severity of TEAEs and SAEs (through Day 85) Safety: Incidence, nature, and severity of TEAEs and SAEs
Key Efficacy Measures Response defined by platelet count increases:
– Doubling of baseline platelet count
– Reaching specific target thresholds
– Increase of ≥20,000 cells/mm³ from baseline		 Evidence of clinical improvement (ECI):
– 1-point improvement on adjusted INCAT score
– 4-point improvement on I-RODS
– 8 kPa improvement on mean grip strength
Timeframe for Efficacy From enrollment to Treatment Day 57-64 Week 14 assessments
Patient Population Participants with Immune Thrombocytopenia Both treatment-naïve and treatment-experienced participants with CIDP
Administration Intravenous Intravenous

FAQ

  • What is NVG-2089 and how does it work? NVG-2089 is an investigational drug designed to mimic the effects of a protein called IVIg (Intravenous Immunoglobulin). It works by attaching (binding) to certain receptors in the body and activating them, which helps reduce inflammation and supports immune system function. This mechanism makes it potentially valuable for treating immune-related disorders like ITP and CIDP.
  • What conditions is NVG-2089 being tested for? NVG-2089 is currently being tested in clinical trials for two specific conditions: Immune Thrombocytopenia (ITP), a disorder that causes low platelet counts and increases bleeding risk, and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), an autoimmune disorder affecting the peripheral nerves that causes weakness and sensory problems.
  • How is NVG-2089 administered to patients in the trials? According to the clinical trial information, NVG-2089 is administered intravenously (IV), meaning it's given directly into a vein. Both trials specify that it's given as an 'intravenous NVG-2089' treatment, though the exact dosing schedule varies between the studies.
  • What are the main goals of the current NVG-2089 clinical trials? The main goals of the current trials are to evaluate the safety, tolerability, and efficacy of NVG-2089. Safety assessments focus on monitoring Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). For efficacy, the ITP trial measures increases in platelet counts, while the CIDP trial looks for improvements in neurological function using specialized scales like the adjusted INCAT score and grip strength measurements.
  • How do researchers determine if NVG-2089 is working effectively? For ITP patients, effectiveness is measured by improvements in platelet counts. Success is defined as either doubling of baseline platelet count or reaching specific target platelet count thresholds (≥50,000 or ≥80,000 cells/mm³ depending on baseline). For CIDP patients, effectiveness is measured by evidence of clinical improvement (ECI), which includes better scores on functional assessments like the adjusted INCAT score, improvements on the Inflammatory Rasch-built Overall Disability Scale (I-RODS), or increased grip strength in the dominant hand.

Ongoing Clinical Trials on NVG-2089

  • Study of NVG-2089 given by intravenous infusion in patients with immune thrombocytopenia to evaluate safety and effectiveness

    Recruiting

    1 1 1
    Investigated drugs:
    Greece Poland Spain

  • Study on the Safety and Effects of NVG-2089 for Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    Not recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria France Italy Poland Spain

Glossary

  • NVG-2089: An investigational drug designed to mimic the effects of IVIg by binding to specific receptors in the body, activating them to reduce inflammation and support immune system function.
  • IVIg: Intravenous Immunoglobulin, a blood product made from the plasma of thousands of healthy donors containing antibodies that help modulate the immune system. NVG-2089 is designed to mimic its effects.
  • Immune Thrombocytopenia (ITP): A disorder that leads to a low platelet count in the blood, which increases the risk of bleeding. It occurs when the immune system mistakenly attacks and destroys platelets.
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): A rare autoimmune disorder that affects the peripheral nerves, causing progressive weakness and impaired sensory function in the legs and arms due to inflammation that damages the protective covering of the nerves.
  • Treatment Emergent Adverse Events (TEAEs): Any unfavorable and unintended sign, symptom, or disease that develops or worsens during the period of a clinical study after treatment has started, whether or not it is considered related to the study treatment.
  • Serious Adverse Events (SAEs): An adverse event that results in death, is life-threatening, requires hospitalization or extension of existing hospitalization, results in persistent disability, or is a congenital anomaly/birth defect.
  • Platelet count: A lab test that measures the number of platelets in a volume of blood, typically expressed as cells per cubic millimeter (cells/mm³). Normal platelet counts range from 150,000 to 450,000 cells/mm³.
  • Adjusted INCAT score: Adjusted Inflammatory Neuropathy Cause and Treatment score, a clinical scale used to measure disability in patients with inflammatory neuropathies like CIDP. Improvements in this score indicate better functional abilities.
  • I-RODS: Inflammatory Rasch-built Overall Disability Scale, a patient-reported outcome measure used to assess disability in inflammatory neuropathies. A higher score indicates less disability.
  • Open-label study: A type of clinical trial in which both the researchers and participants know which treatment is being administered, as opposed to a blinded study where this information is concealed.
  • Intra-participant dose escalation: A clinical trial design where each participant starts with a low dose of the drug that is gradually increased over time to determine the optimal dose while monitoring for safety.
  • Treatment-naïve: Refers to patients who have not previously received a specific treatment for their condition.
  • Treatment-experienced: Refers to patients who have previously received treatment for their condition.
  • Evidence of clinical improvement (ECI): In the CIDP trial, this is defined as improvement of 1 point on the adjusted INCAT score, 4 points on I-RODS, or 8 kilopascal (kPa) on mean grip strength in the dominant hand.
  • Phase 2 clinical trial: A stage of clinical research that focuses on evaluating the effectiveness of a drug, determining optimal dosage, and continuing to monitor safety in a larger group of patients than in Phase 1.

References

  1. https://clinicaltrials.gov/study/NCT07095127
  2. https://clinicaltrials.gov/study/NCT07027111