Landos Biopharma Publishes Results of NX-13 Phase 1b Study in Ulcerative Colitis in Journal of Crohn’s and Colitis

NX-13, a Novel, Oral, NLRX1 Agonist, was Observed to be Well Tolerated and Demonstrated Early Signs of Rapid Symptomatic Relief and Endoscopic Improvement in Patients with Ulcerative Colitis

NEXUS Phase 2 Proof-of-Concept Study is Ongoing, with Top-Line Readout Expected in Q4 2024

NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced a peer-reviewed publication describing the safety, tolerability, pharmacokinetic and clinical efficacy results for the NX-13 Phase 1b trial in patients with ulcerative colitis (UC) in the Journal of Crohn’s and Colitis.

“We are delighted to have our Phase 1b results of NX-13 in UC published in the Journal of Crohn’s and Colitis,” said Dr. Fabio Cataldi, Executive Vice-President & Chief Medical Officer at Landos. “The publication highlights the promising data that are the foundation for our ongoing NEXUS Phase 2 trial, which is on track for top-line readout in the fourth quarter of 2024.”

The publication, titled "The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study”, reports the results of the Phase 1b trial which included 38 patients randomized to placebo (n=5), 250mg immediate release (IR) of NX-13 (n=11), 500mg IR of NX-13 (n=11) or 500mg delayed release NX-13 (n=11). NX-13 was found to be well tolerated in all patients studied. No deaths or severe adverse events were reported and all adverse events were mild to moderate.

The majority of patients treated with NX-13 for four weeks showed consistent and rapid clinical improvement in total Mayo score and in symptoms relief (as measured by rectal bleeding and stool frequency). Additionally, the endoscopic improvement observed correlated closely with symptoms improvement.

“Despite advances in UC treatments, the need for new and novel therapies such as NX-13 remains highly important for patients,” commented Bram Verstockt, M.D., Ph.D., and lead author. “The early signs of efficacy, along with a favorable safety profile, highlighted in this publication are encouraging. I am excited about the potential of NX-13 and immunometabolism in breaking the inflammatory cycle in UC, which remains a significant unmet need in effectively treating patients.”