NVG-2089 / Nuvig Therapeutics - LARVOL DELTA

A recombinant IgG1 Fc-domain protein ameliorates inflammatory demyelinating peripheral neuropathy. (PubMed, Front Immunol) - "Both NVG-2089 and IVIg stabilized motor and sensory performance, preserved compound muscle action potential (CMAP) amplitudes, and attenuated demyelination-associated prolongation of distal latency and CMAP duration. NVG-2089 demonstrated robust neuroprotective efficacy comparable to IVIg while requiring a substantially lower protein dose. These findings support NVG-2089 as a promising, dose-efficient alternative to IVIg for the treatment of inflammatory demyelinating neuropathies, including GBS and CIDP."

Journal • Immunology • Inflammation • Pain • ENTPD1 • IL2RA

NVG-2089-200: Safety, Tolerability, and Efficacy of NVG-2089 in Participants with Immune Thrombocytopenia (clinicaltrialsregister.eu) - P1/2 | N=42 | Recruiting | Sponsor: Nuvig Therapeutics Inc. | N=25 ➔ 42

Enrollment change • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Nuvig Therapeutics, Inc. | N=10 ➔ 30 | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Enrollment change • Trial completion date • Trial primary completion date • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

INVGOR: Safety, Tolerability, and Efficacy of NVG-2089 in Participants With CIDP (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Nuvig Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2028 ➔ Jul 2026 | Trial primary completion date: Jun 2027 ➔ Jul 2026

Enrollment closed • Trial completion date • Trial initiation date • Trial primary completion date • Pain

Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Nuvig Therapeutics, Inc.

New P2 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

INVGOR: Safety, Tolerability, and Efficacy of NVG-2089 in Participants With CIDP (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Nuvig Therapeutics, Inc.

New P2 trial • Pain

A PHASE 1 HEALTHY VOLUNTEER DOSE ESCALATION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS (PK), AND PHARMACODYNAMICS (PD) OF INTRAVENOUS HUMAN IGG1 FC-F241A (NVG-2089) FOR THE TREATMENT OF ITP (EHA 2025) - "NVG-2089 was well tolerated in healthy subjects with exposures that will enable dosing intervals of 2-4 weeks to achieve modeled efficacious exposures. PD responses following treatment with NVG-2089 were consistent with that observed in humans following treatment with 1-2g/kg IVIg. These data support further development of NVG-2089 in patients with ITP and other autoimmune diseases."

Clinical • P1 data • PK/PD data • Immunology • ENTPD1 • FCER2