Nuvig Therapeutics Initiates Phase 2 Trial of Novel CIDP Treatment NVG-2089
Key Insights
Nuvig Therapeutics (search) has dosed the first patient in its Phase 2 INVGOR trial evaluating NVG-2089, a recombinant Fc (search) fusion protein designed to replicate immunomodulatory functions of IVIg for chronic inflammatory demyelinating polyneuropathy (search) (CIDP (search)).
The global multicenter trial will enroll up to 60 participants across approximately 40 sites, including both treatment-naive patients and those transitioning from intravenous immunoglobulin therapy.
Phase 1 results demonstrated NVG-2089 was well-tolerated with no serious adverse events, offering potential advantages in consistency, scalability, and patient convenience compared to plasma-derived IVIg.
Nuvig Therapeutics (search) has announced the dosing of the first patient in its Phase 2 clinical trial evaluating NVG-2089 for the treatment of chronic inflammatory demyelinating polyneuropathy (search) (CIDP (search)). The announcement represents a significant milestone in the company's development of novel immunomodulatory therapeutics for autoimmune diseases.
NVG-2089 is a recombinant Fc (search) fusion protein specifically designed to replicate key immunomodulatory functions of intravenous immunoglobulin (IVIg), the current standard treatment for CIDP (search). The investigational therapy aims to provide greater consistency, scalability, and patient convenience compared to plasma-derived IVIg products.
"Dosing the first patient in our Phase 2 CIDP (search) trial marks an important step forward in our mission to deliver targeted, mechanism-based immunomodulation for patients with autoimmune diseases," said Alan Glicklich, M.D., Chief Medical Officer of Nuvig Therapeutics (search). "We are encouraged by the safety and pharmacodynamic data observed in our Phase 1 study and look forward to evaluating NVG-2089 in individuals living with CIDP, a condition that remains underserved by currently available therapies."
The INVGOR Trial Design
The Phase 2 study, named INVGOR, is a multicenter, global trial that will evaluate the safety, tolerability, and potential clinical benefit of NVG-2089 in up to 60 participants with CIDP (search). The trial is being conducted at approximately 40 sites worldwide and includes two patient populations:
- Patients currently treated with IVIg who will transition to NVG-2089
- Treatment-naive patients who have not previously received therapy
The trial will assess multiple endpoints, including the percentage of treatment-naive patients achieving evidence of clinical improvement (ECI) at Week 14, and the percentage of IVIg-experienced patients achieving either ECI at Week 14 or stability of disease as measured by adjusted inflammatory neuropathy cause and treatment (INCAT) score between Weeks 4 and 14.
Promising Phase 1 Results
Nuvig also announced that it will present results from its Phase 1 study of NVG-2089 in healthy volunteers at the 2025 Peripheral Nerve Society (PNS) Annual Meeting on May 19th in Edinburgh, Scotland. The Phase 1 data showed that NVG-2089 was well-tolerated with no serious or severe adverse events, supporting its advancement into Phase 2 development for CIDP (search).
The recombinant production of NVG-2089 offers potential advantages over plasma-derived IVIg, including improved manufacturing scalability and batch-to-batch consistency. These attributes could help address supply challenges that have historically affected IVIg availability.
Addressing Unmet Needs in CIDP
CIDP (search) is an autoimmune disorder characterized by progressive weakness and sensory impairment in the arms and legs due to immune-mediated damage to peripheral nerves. Current treatment options, while effective for many patients, come with significant limitations.
"There remains a considerable unmet need for CIDP (search) therapies that are effective, non-immunosuppressive, well tolerated, and more convenient than current therapies," said Jeffrey Allen, M.D., Professor of Neurology at the University of Minnesota Medical School. "We welcome the development of new treatment options such as NVG-2089 that aim to address these limitations and improve patient outcomes."
Company Momentum
The initiation of the Phase 2 CIDP (search) trial follows Nuvig's successful Series B funding round in December 2024, which secured $161 million to advance its preclinical pipeline and facilitate clinical proof-of-concept trials for NVG-2089.
As a privately held biotechnology company, Nuvig Therapeutics (search) is focused on developing novel immunomodulatory therapeutics for patients with inflammatory autoimmune diseases. The progress of NVG-2089 represents a significant step in the company's mission to deliver innovative treatments for conditions with substantial unmet medical needs.