Promising Results for NVG-2089 in Clinical Trials for Immune-Related Disorders

What is NVG-2089?

NVG-2089 is an investigational medication currently being developed for treating autoimmune conditions12. 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 to12:

• 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 pathways12.

Conditions Treated with NVG-2089

Based on current clinical trials, NVG-2089 is being investigated for the treatment of two main autoimmune conditions12:

• 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 platelets1.

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 counts1.

Researchers consider the treatment successful if1:

• 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 legs2.

The clinical trial for CIDP includes two groups of participants2:

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 group2:

• 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 ongoing12:

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 effectiveness1.
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 efficacy2.

"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 receiving12.

Safety Information

As with any investigational treatment, safety is a primary concern. Both clinical trials for NVG-2089 are designed to carefully monitor12:

• 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 days1, while the CIDP study monitors participants through 14 weeks of treatment2.

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 trials12.