Nuvig Therapeutics has dosed the first subject in its multi-centre Phase II INVGOR trial of recombinant human immunoglobulin G1-crystallisable fragment (IgG1-Fc) fusion protein, NVG-2089, for individuals with chronic inflammatory demyelinating polyneuropathy (CIDP).

The global trial aims to assess the tolerability, clinical benefit and safety of NVG-2089 in up to 60 CIDP subjects.

It is being carried out across nearly 40 sites worldwide, and will include subjects treated currently with intravenous immunoglobulin (IVIg) transitioning to the therapy and those who have not received prior treatment.

Nuvig noted that the trial will measure the percentage of treatment-naive subjects achieving evidence of clinical improvement (ECI) at week 14, as well as IVIg treatment-experienced subjects achieving ECI, or disease stability measured between weeks 4 and 14 by adjusted inflammatory neuropathy cause and treatment (INCAT) score.

The therapy was found to be well-tolerated in the Phase I trial, without any severe adverse events or discontinuations.

NVG-2089 is tailored to imitate IVIg’s immunomodulatory mechanisms.

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According to the company, the therapy’s recombinant production offers potential advantages over plasma-derived IVIg, including scalability and consistency.

CIDP is an autoimmune disorder causing progressive weakness and sensory impairment in the arms and legs.

Nuvig Therapeutics’ chief medical officer Alan Glicklich said: “Dosing the first patient in our Phase II CIDP trial marks an important step forward in our mission to deliver targeted, mechanism-based immunomodulation for patients with autoimmune diseases.

“We are encouraged by the safety and pharmacodynamic data observed in our Phase I study and look forward to evaluating NVG-2089 in individuals living with CIDP, a condition that remains underserved by currently available therapies.”

In December 2024, the company secured $161m in a Series B funding round to progress its preclinical pipeline and facilitate NVG-2089’s clinical proof-of-concept trials.

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