Benzinga | Apr 29, 2021 07:26AM EDT

Landos Biopharma Announces First Patient Dosed In A Phase 1b Study of NX-13 For Ulcerative Colitis

Landos Biopharma (NASDAQ:LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, today announced that the Company dosed the first patient in a Phase 1b study of NX-13 for ulcerative colitis (UC). NX-13 is Landos' potentially first-in-class, novel, orally administered, gut-restricted NLRX1 agonist for the treatment of UC and Crohn's disease (CD).

"UC is a chronic and debilitating disease that impairs the quality of life of millions of patients worldwide, with many relapsing in less than a year after receiving currently available therapies. Our novel oral product candidate, NX-13, is designed to initiate a robust multimodal mechanism and restore immune tolerance in patients with UC, both as a single agent or in combination with other therapeutics," commented Josep Bassaganya-Riera, Ph.D., Chairman, President, and CEO of Landos Biopharma. "Our rapid advancement of NX-13 to a Phase 1b trial in just over a year is supportive of our differentiated approach to target the NLRX1 pathway, which can favorably modulate epithelial barrier integrity and interactions with the gut microbiome, while decreasing reactive oxygen species formation and inflammation in the GI tract. As our second first-in-class product candidate to enter the clinic, NX-13 is quickly progressing through clinical development in UC and will soon enter clinical testing for CD as well as for other autoimmune diseases."

The Phase 1b study is a randomized, placebo-controlled, double-blind, multicenter, dose ranging study, evaluating 40 subjects with active UC over 28 days. All subjects will be randomized to receive one of the three NX-13 treatment regimens: 250 mg immediate release tablets (IR), 500 mg IR, 500 mg modified release tablets (MR) or placebo. The objective of the trial will be to evaluate the safety and pharmacokinetics of multiple dose levels of NX-13 in patients. Exploratory biomarkers of response to treatment, including fecal calprotectin, will also be evaluated. In March, Landos announced successful completion of a Phase 1a study of NX-13 in normal healthy volunteers, which identified a maximum tolerated dose 10-fold greater than the anticipated therapeutic dose, validated the gut-restricted profile of NX-13, and demonstrated a preliminary signal of response in reduction of fecal calprotectin levels.

"After clearing 5 investigational new drug applications with the FDA and with three clinical trials completed, a Phase 2 trial for omilancor about to be initiated in CD, in addition to the Phase 1b trial of NX-13 in UC patients, we continue to accelerate the clinical development of our top product candidates in our expansive therapeutic pipeline. We expect to quickly report topline data for this Phase 1b trial of NX-13 in the first quarter of 2022," said Jyoti Chauhan, EVP of Operations & Regulatory Affairs of Landos Biopharma