Nuvig Therapeutics Begins Phase 2 CIDP Trial of NVG-2089 and Shares Phase 1 Data

Nuvig Therapeutics, Inc., a biotechnology firm based in Menlo Park, California, is pioneering advancements in immunomodulatory therapeutics for inflammatory autoimmune conditions. Recently, the company has taken a significant step in its research endeavors by dosing the first participant in its Phase 2 clinical trial of NVG-2089, aimed at treating chronic inflammatory demyelinating polyneuropathy (CIDP). This development marks a promising progression in Nuvig's mission to deliver innovative treatments for autoimmune diseases, as emphasized by Alan Glicklich, M.D., the Chief Medical Officer at Nuvig, who noted the importance of this advancement in providing mechanism-based immunomodulation for such conditions.

The ongoing Phase 2 study, named INVGOR, is designed as a multicenter, international trial assessing the safety, tolerability, and potential efficacy of NVG-2089 in up to 60 patients suffering from CIDP. This trial involves individuals who are transitioning from intravenous immunoglobulin (IVIg) therapy to NVG-2089, as well as those who have not previously undergone treatment. Conducted across approximately 40 sites globally, the study aims to evaluate not only the safety and tolerability of NVG-2089 but also its clinical benefits. Specifically, it will assess the percentage of treatment-naive patients who show clinical improvement by the 14th week and the percentage of those with prior IVIg treatment who achieve similar outcomes or maintain disease stability between weeks 4 and 14 based on adjusted INCAT scores.

Jeffrey Allen, M.D., a Professor of Neurology at the University of Minnesota Medical School, highlighted the existing need for CIDP treatments that are effective without being immunosuppressive, well-tolerated, and offer convenience over current therapies. He welcomed the introduction of NVG-2089 as a potential solution to these challenges, aiming to enhance patient outcomes.

In conjunction with this trial, Nuvig is preparing to present findings from a Phase 1 study of NVG-2089 at the 2025 Peripheral Nerve Society Annual Meeting, slated for May 19th in Edinburgh, Scotland. The initial study demonstrated favorable results, with NVG-2089 being well-tolerated and showing no serious or severe adverse events, nor any discontinuations due to adverse effects. This presentation underscores the continued clinical momentum and interest in NVG-2089 as a promising therapeutic candidate.

NVG-2089 itself represents a novel approach in treating autoimmune diseases. It is a recombinant human IgG1-Fc fusion protein designed to imitate the immunomodulatory effects of IVIg, the standard treatment for various autoimmune disorders. Unlike plasma-derived IVIg, NVG-2089 is produced recombinantly, offering potential advantages in consistency, scalability, and ease of administration. By selectively targeting anti-inflammatory pathways without broadly suppressing the immune system, NVG-2089 is being developed as a next-generation alternative, aiming to overcome the limitations of IVIg in terms of supply, tolerability, and the burden of administration.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is characterized by progressive weakness and impaired sensory function in the limbs. Patients often experience muscle weakness, difficulty with tasks requiring fine motor skills, and sensory disturbances such as numbness or tingling. These symptoms can vary in severity and typically progress over several months, with diagnosis confirmed through nerve conduction studies indicating demyelination, alongside cerebrospinal fluid analysis showing elevated protein levels.

Nuvig Therapeutics is dedicated to advancing innovative immune therapeutics for chronic inflammatory and autoimmune diseases, with NVG-2089 leading the company's pipeline. Designed to precisely target type II Fc receptors, NVG-2089 promotes the expression of FcgRIIb, expands T regulatory cells, and downregulates various inflammatory pathways, positioning it as a transformational candidate in autoimmune disease treatment.