Rationale Behind NVG-2089 as New Therapy for CIDP: Pamela Conley; Alan Glicklich, MD

WATCH TIME: 3 minutes

"We think there's a reason to believe that our pleiotropic mechanism could lead to better efficacy than existing options—and without the immunosuppressive concerns or tolerability issues seen with other therapies."

There were a number of agents on display at the 2025 Peripheral Nervous System (PNS) Annual Meeting, held May 17-20 in Edinburgh, Scotland, including Nuvig Therapeutics’ NVG-2089, an investigational drug for chronic inflammatory demyelination polyneuropathy (CIDP). This agent, a recombinant human IgG1-Fc fusion protein designed to mimic the key immunomodulatory mechanisms of intravenous immunoglobulin (IVIg), was tested in a phase 1 study of healthy volunteers, with results presented at the meeting.

The SAD cohort, testing single intravenous infusion doses of 9, 30, 100, 250, or 500 mg/kg NVG-2089, comprised 40 healthy individuals, whereas the MAD included 16 participants who were randomly assigned to 3 biweekly doses of 150 or 300 mg/kg of NVG-2089 or placebo. Overall, across both cohorts, NVG-2089 was shown to be well tolerated, with no serious adverse events (AEs) observed, nor any early terminations related to AEs. In addition, the exposure was linear across the range of tested doses, with a half-life spanning from 11-12 days.

Following the meeting, NeurologyLive^® sat down with Pamela Conley, chief scientific officer and interim chief executive officer at Nuvig, as well as Alan Glicklich, MD, chief medical officer, to discuss how NVG-2089 would address the limitations of current CIDP treatment landscape. The duo provided commentary on the pleiotropic mechanism of action behind the agent, how it stacks up against standard-of-care IVIg, and what the early safety profile looks like. Furthermore, Conley and Glicklich highlighted how NVG-2089 may outperform emerging therapies like FcRn and complement inhibitors by avoiding immunosuppression and infection risks, positioning it as a potentially best-in-class option for patients with CIDP.

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REFERENCE
1. Coffey G, Oguno B, Avery B, et al. Phase I Healthy Volunteer Safety and PK/PD with NVG-2089 (Human IgG1-Fc-F241A) Supports Development in CIDP. Presented at: 2025 PNS Annual Meeting; May 17-20; Edinburgh, Scotland. ABSTRACT P314