NovaRock Biotherapeutics Announces FDA Approval of IND Application for NBL-012 to Treat Inflammatory Diseases
Ewing, NJ, January 6, 2021 – NovaRock Biotherapeutics Ltd, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for NBL-012, a fully human antibody, for treating chronic inflammatory diseases such as psoriasis, hidradenitis suppurativa (HS), inflammatory bowel disease (IBD) and other autoimmune diseases. The Phase I clinical trial will evaluate the safety and tolerability as well as the exposure and pharmacokinetic profile of NBL-012.
IL-23 p19 is an emerging target for various autoimmune diseases including psoriasis, hidradenitis suppurativa (HS) and inflammatory bowel disease (IBD). Targeting IL-23p19 has demonstrated superior clinical efficacy and safety compared with targeting TNF-α, IL-17 or IL-23p40 . NBL-012 is a novel potent and specific IL-23p19 antibody. It acts upstream of the IL-23/IL-17 inflammatory axis, leading to sustained inhibition of Th17 cell function and IL-17 production in patients. As a fully human IgG4 antibody, NBL-012 carries fewer risks of immunogenicity and undesirable Fc-mediated tissue damage. The expedited development of NBL-012 will bring new and effective treatment options to patients with autoimmune diseases around the world.
About NovaRock Biotherapeutics Limited
NovaRock Biotherapeutics is an innovative and dynamic biotech company dedicated to the discovery and development of antibody therapies for cancer and autoimmune diseases in the U.S. Currently privately held, the company was founded in January 2018 in the Princeton area of New Jersey. NBL-012 is the first molecule entering clinical studies from the robust pipeline of NovaRock Biotherapeutics, marking the 3-year-old company advancing into the clinical development stage. Several other monoclonal and multi-specific antibody molecules in its pipeline are anticipated to enter clinical studies soon. To learn more, please visit www.novarockbio.com.