Nuvig Therapeutics, Inc. (“Nuvig” or the “Company”), a privately held biotechnology company developing novel immunomodulatory therapeutics for patients with inflammatory autoimmune diseases, today announced the first-in-human dosing of NVG-2089, a proprietary product being developed to treat patients with inflammatory myopathies and severe dermatologic autoimmune disease. Nuvig also announced that the FDA granted fast track designation (FTD) for NVG-2089’s development in bullous pemphigoid.

NVG-2089 is a novel, recombinant, non-immunosuppressive immunomodulator designed to target type II Fc receptors and trigger an endogenous regulatory mechanism that reduces autoimmune dysregulation. NVG-2089 has demonstrated powerful anti-inflammatory effects in animal models that are characterized by activated B cells, T cells, and certain myeloid immune cells. NVG-2089 has been well-tolerated in animal toxicology studies thus far.

“We are delighted to advance the clinical development of NVG-2089,” said Julie Anne Smith, Chief Executive Officer of Nuvig Therapeutics. “We are looking forward to investigating NVG-2089 in multiple autoimmune diseases where a next-generation immunomodulatory therapy could have important safety and efficacy advantages over existing therapies.”

The primary objective of the study is to assess the safety and tolerability of NVG-2089. Secondary objectives will evaluate the pharmacokinetics and pharmacodynamics of the drug. Following completion of the Phase 1 study, Nuvig plans to initiate proof-of concept studies in patients with inflammatory myopathies and severe dermatologic autoimmune diseases.

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 FcγRIIb and causes the expansion of T regulatory cells and the downregulation of numerous inflammatory pathways. Nuvig is based in Redwood City, California. For more information, please visit www.nuvigtherapeutics.com.

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