Nuvig Therapeutics, Inc.

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- 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 .

Physician and biopharmaceutical leadership executive with extensive experience in novel drug development, operations management, and team building REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Nuvig Therapeutics, Inc., a private biotech company developing novel biologic therapeutics to treat inflammatory autoimmune diseases, announced today the appointment of Alan Glicklich, M.D., as Chief Medical Officer. Dr. Glicklich has more than 25 years of experience in biotech companies advancing novel drug candidates across all stages of development and building teams to ensure quality and safety. “Alan is an experienced drug developer of novel medicines for rare diseases. He is passionate about improving the health and quality of life for patients,” said Julie Anne Smith, Chief Executive Officer of Nuvig Therapeutics. “In addition, Alan’s natural acumen for hiring talent is critical as we build a powerhouse at Nuvig, and I’m delighted to welcome him to the team.” Dr. Glicklich added, “What excites me about Nuvig is the unique therapeutic approach and the possibilities it has to improve and extend the lives of patients with chronic inflammatory autoimmune diseases. I look forward to working with the high-caliber team at Nuvig to advance our clinical programs to maximize the therapeutic impact of this incredible opportunity in medicine.” Prior to Nuvig, Dr. Glicklich was the Chief Medical Officer at Chinook Therapeutics, where he focused on biologics and small molecules for rare, chronic kidney diseases. While at Chinook, he built teams responsible for clinical development, clinical operations, medical affairs, biometrics, and regulatory pharmacovigilance. In addition, he designed and operationalized a successful Phase 3 registrational study for atrasentan, a novel, selective endothelin A receptor antagonist (SERA). Before working at Chinook, Dr. Glicklich was the Chief Medical Officer at Bird Rock Bio, focusing on monoclonal antibody development for inflammatory and fibrotic diseases. Prior to Bird Rock Bio, he was the Vice President of Clinical Development at Arena Pharmaceuticals where he designed and oversaw operations for several Phase 2 programs, including ralinepag in pulmonary artery hypertension and the etrasimod program for ulcerative colitis. Earlier in his career Dr. Glicklich held positions at Bristol Myers Squibb, Sanofi-Aventis, and Regeneron. Dr. Glicklich received a B.A. in biology from the University of Chicago and an M.D. from the University of Wisconsin. He also holds an MBA from Emory University Goizueta Business School. About Nuvig Therapeutics Nuvig Therapeutics is advancing an innovative and transformational pipeline of novel immune therapeutics for chronic inflammatory and autoimmune diseases. For more info, visit .

REDWOOD CITY, Calif.--( BUSINESS WIRE )-- Nuvig Therapeutics, Inc. , a biopharma company developing proprietary recombinant human therapeutics for patients with autoimmune diseases, today announced the appointment of Julie Anne Smith as Chief Executive Officer (CEO) and member of the Board of Directors. Ms. Smith has over 20 years of experience in the life science industry, with a focus on leading private and public biotech companies through development and commercialization of therapeutics for orphan diseases. Pamela Conley, Ph.D., cofounder and founding CEO of Nuvig Therapeutics, will serve as the Company’s Chief Scientific Officer. “The board is very grateful to Pam for leading Nuvig from inception to this exciting inflection point, as the company enters IND-enabling activities for its lead program,” said Kenneth Harrison, Ph.D., Director of Nuvig Therapeutics and Partner at Novo Ventures. “We are excited by the dynamic leadership, vision, and experience Julie brings to the company and look forward to working closely with her to advance Nuvig’s therapies to patients.” Nuvig’s lead program is a novel recombinant human antibody fragment engineered to induce immune modulatory mechanisms that restore immune homeostasis and control inflammation in autoimmune diseases. Nuvig is extending this technology to build a pipeline of differentiated protein therapeutics that can be used in the context of varied but well-defined inflammatory and autoimmune diseases. “I’m delighted to join Nuvig at this pivotal time as the team has received strong investor support and rapidly advanced its novel technology to the IND-enabling stage,” said Ms. Smith. “I look forward to working with Pam and the team to propel our development candidates into the clinic with the goal of providing new therapeutic options for autoimmune diseases without broad immunosuppression.” Prior to Nuvig, Ms. Smith served as President and CEO of ESCAPE Bio, a biotech company developing precisely targeted therapies for genetic forms of neurodegeneration. She previously served as President and CEO of Raptor Pharmaceuticals, which developed and commercialized therapies for the orphan disease nephropathic cystinosis and chronic pulmonary infections before its acquisition by Horizon Pharmaceuticals. Ms. Smith also served as Chief Commercial Officer of Enobia Pharmaceuticals until it was acquired by Alexion Pharmaceuticals. Earlier in her career, she held roles at Jazz Pharmaceuticals, Genzyme, Novazyme, and Bristol-Myers Squibb. Ms. Smith serves as a director on the Boards of Exelixis (Nasdaq: EXEL) and Stoke Therapeutics (Nasdaq: STOK). Ms. Smith obtained her B.S. in biology from Cornell University. About Nuvig Therapeutics Nuvig Therapeutics is advancing innovative and transformational therapies that are designed to induce natural mechanisms to restore immune homeostasis, rebalance immune function following inflammation, and improve the treatment options for patients. Nuvig is building a pipeline of novel immune therapeutics for chronic inflammatory and autoimmune diseases. For more info, visit www.nuvigtherapeutics.com .