NX-13 is the Company’s second first-in-class candidate to begin clinical development

BLACKSBURG, Va., July 14, 2020 — Landos Biopharma, a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune disease, today announced that the first patient has been dosed in a Phase 1 study of NX-13, the Company’s novel, orally administered therapeutic candidate for the treatment of inflammatory bowel disease.

“Today marks a significant milestone for Landos, as we advance our second product candidate, NX-13, into clinical development,” commented Josep Bassaganya-Riera, Ph.D., Chairman, President, and CEO of Landos Biopharma. “This achievement highlights the success of our precision medicine platform in identifying novel targets to establish a robust and differentiated therapeutic pipeline for autoimmune disease. NX-13 is a compound for oral administration that targets the NLRX1 receptor, which is part of a pathway that modulates immune response linked to inflammatory bowel disease. We believe that, if approved, NX-13 could provide an additional treatment option to the up to 50 percent of ulcerative colitis patients that experience relapse within 1 year of current therapies and up to 70-90 percent of Crohn’s disease patients that fail to enter prolonged remission.”

The randomized, double-blind, placebo-controlled, ascending dose, multi-cohort Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of NX-13 in healthy volunteers. The study design includes evaluation of single ascending doses and multiple ascending doses of NX-13. Based on observations in preclinical models of inflammatory disease, NX-13 has the potential to be developed as a monotherapy or in combination with other therapeutics in the treatment of inflammatory bowel disease.

“Advancing two first-in-class oral products for Crohn’s disease and ulcerative colitis with new mechanisms of action into clinical development in less than 2 years is a substantial accomplishment,” said Jean-Frederic Colombel, M.D., a Clinical Advisory Board member for Landos’ IBD program, gastroenterologist and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. “We continue to see an unmet clinical need for chronic oral therapies to treat UC and CD with improved efficacy, safety, tolerability and convenience, including in the mild to moderate patients.”

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic autoimmune disorder with two primary subtypes: Crohn’s disease and ulcerative colitis, which impair quality of life and afflict over five million individuals worldwide.1 Currently, available therapeutics typically are only able to address a subset of overall patient populations and many fail to maintain therapeutic efficacy over time. In addition, current therapeutics are associated with serious side effects and toxicities related to systemic immunosuppression, including increased mortality.2

1. World IBD Day. Home. Available at http://www.worldibdday.org/index.html. Accessed July 2020.
2. Shivaji, U.N. et al., Review article: managing the adverse events caused by anti-TNF therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Mar;49(6):664-680.

About NX-13

NX-13 is a first-in-class, orally-active, gut-restricted, small molecule therapeutic candidate for the treatment of inflammatory bowel disease. NX-13 targets NLRX1, a mitochondria-associated receptor with the ability to modulate immune responses. By activating the NLRX1 pathway, NX-13 increases oxidative phosphorylation in immune cells, reduces differentiation of effector CD4-positive T cells, and decreases production of inflammatory cytokines.

About Landos Biopharma

Landos Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of first-in-class oral therapeutics for patients with autoimmune disease. Lead asset BT-11 is a novel, first-in-class, oral, gut-restricted therapeutic candidate for the treatment of ulcerative colitis and Crohn’s disease that targets the LANCL2 pathway. NX-13 is a novel, first-in-class, oral, gut-restricted compound for the treatment of inflammatory bowel disease, which targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. For more information, please visit www.landosbiopharma.com.

Contacts:
Thomas Hoffmann (investors)
Solebury Trout
646-378-2931
[email protected]

Rich Allan (media)
Solebury Trout
646-378-2958
[email protected]