- NVG-2089 is a recombinant Fc fusion protein designed to replicate key immunomodulatory functions of IVIg with greater consistency, scalability, and patient convenience
- Phase 1 data show NVG-2089 was well tolerated with no serious or severe adverse events, supporting advancement into Phase 2 development for CIDP
MENLO PARK, Calif.--(BUSINESS WIRE)--#autoimmunediseases--Nuvig Therapeutics, Inc. (“Nuvig”), a privately held biotechnology company developing novel immunomodulatory therapeutics for patients with inflammatory autoimmune diseases, today announced that the first patient has been dosed in its Phase 2 clinical trial evaluating NVG-2089 in individuals with chronic inflammatory demyelinating polyneuropathy (CIDP). The company also announced that it will present results from a Phase 1 study of NVG-2089 in healthy volunteers at the 2025 Peripheral Nerve Society (PNS) Annual Meeting on May 19th in Edinburgh, Scotland.
“Dosing the first patient in our Phase 2 CIDP 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. “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 Phase 2 study, called INVGOR, is a multicenter, global trial evaluating the safety, tolerability, and potential clinical benefit of NVG-2089 in up to 60 participants with CIDP. The trial includes patients currently treated with intravenous immunoglobulin (IVIg) who will transition to NVG-2089 and patients who have not previously been treated. The INVGOR trial is being conducted at approximately 40 sites globally. It will evaluate the safety and tolerability of NVG-2089, as well as evaluating the percentage of treatment naive patients achieving evidence of clinical improvement (ECI) at Week 14, and the percentage of IVIg treatment experienced patients achieving ECI at week 14 or stability of disease as measured by adjusted INCAT score between weeks 4 and 14.
“There remains a considerable unmet need for CIDP 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.”
Presentation of the Phase 1 findings at the upcoming PNS meeting reflects the continued clinical momentum behind NVG-2089. In the Phase 1 study, NVG-2089 was well tolerated, with no serious adverse events, no severe adverse events, and no discontinuations due to adverse events.
About NVG-2089
NVG-2089 is a recombinant human IgG1-Fc fusion protein designed to mimic the key immunomodulatory mechanisms of intravenous immunoglobulin (IVIg), the current standard of care for a range of autoimmune diseases. Unlike plasma-derived IVIg, NVG-2089 is produced recombinantly, offering the potential for improved consistency, scalability, and patient convenience. By selectively engaging anti-inflammatory pathways without broadly suppressing the immune system, NVG-2089 is being developed as a next-generation alternative to IVIg with the goal of addressing its limitations in supply, tolerability, and administration burden.
About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a neurological autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms. Symptoms typically include symmetrical muscle weakness leading to difficulties with walking, climbing stairs, and performing fine motor tasks. Sensory disturbances such as numbness, tingling, or burning sensations. Additionally, diminished or absent reflexes are a common clinical finding. Fatigue is frequent, significantly impacting the patient’s quality of life. CIDP symptoms can vary in severity and may progress over several months. Diagnosis is typically confirmed through nerve conduction studies, which reveal demyelination, and cerebrospinal fluid analysis showing elevated protein levels.
About Nuvig Therapeutics
Nuvig Therapeutics is a clinical-stage biotechnology company that is advancing an innovative and transformational pipeline of novel immune therapeutics for chronic inflammatory and autoimmune diseases. The Company’s lead investigational drug candidate, NVG-2089, is an engineered Fc fragment designed to precisely target type II Fc receptors. When NVG-2089 binds to its target, it upregulates the expression of FcgRIIb and causes the expansion of T regulatory cells and the downregulation of numerous inflammatory pathways. Nuvig is based in Menlo Park, California. For more information, please visit www.nuvigtherapeutics.com.
Contacts
Corporate: info@nuvigtx.com
Clinical Trial Info: clinicaltrials@nuvigtx.com
Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com
