New research findings to be presented at Digestive Disease Week 2026 demonstrate that NIM-1324 outperforms current IBD medications and establish Phase 1 safety and tolerability in humans

Phase 2-ready NIM-1324 is a derisked, safe and well-tolerated, oral, once-daily, small molecule LANCL2 therapeutic for ulcerative colitis and Crohn’s disease, with several follow-on indications for other inflammatory and autoimmune diseases in progress

NIM-1324’s mechanism of action—the LANCL2 pathway—is clinically validated in biologic-naïve and biologic-exposed ulcerative colitis and Crohn’s disease patients, offering first-in-class potential

A well-powered, proof-of-concept Phase 2 clinical trial of NIM-1324 will test 125, 250, and 1000 mg doses versus placebo in moderate-to-severe ulcerative colitis patients to evaluate clinical remission and target engagement

NImmune Biopharma (“NImmune”), a private late-stage precision inflammation and immunology (“I&I”) biopharmaceutical company, today announced that Executive Chairman, President and CEO Dr. Josep Bassaganya-Riera will be launching a new clinical program and business venture to develop NIM-1324 as its lead asset focused on inflammatory bowel disease (IBD), with follow-on I&I indications, including lupus and psoriasis.

“I am eager to launch my latest business venture for the clinical development of NIM-1324 and continue building on the incredible successes addressing unmet clinical needs of patients we’ve seen across the LANCL2 therapeutic portfolio,” said Dr. Bassaganya-Riera. “Advancing NIM-1324 to Phase 2 clinical testing in ulcerative colitis (UC) patients is a significant step forward and takes us closer to achieving its full potential as a once-daily, oral LANCL2 therapeutic for IBD with first-in-class potential.”

At Digestive Disease Week (DDW) 2026, the NIMML Institute will present two new abstracts entitled: “Safety, Tolerability and LANCL2 Target Engagement of NIM-1324 in a Randomized, Double-Blind, Placebo-Controlled Phase I Study” and “NIM-1324: A Next-Generation LANCL2 Therapeutic Outperforms Current IBD Medications.” DDW is one of the world’s largest gatherings of physicians, researchers, and industry professionals in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. The meeting features peer-reviewed scientific abstracts highlighting innovative therapeutic programs that may transform gastroenterology clinical practice and patient care.

NIM-1324 is an investigational, oral, once-daily, small molecule LANCL2 therapeutic for IBD. The program leverages biomarker-driven precision immunology and a novel immunometabolic mechanism aimed at activating regulatory T cells (Tregs) to re-establish immune tolerance at sites of inflammation. In its first-in-human clinical trial, NIM-1324 met all primary and secondary endpoints, demonstrated a favorable safety profile with no dose limiting toxicities, and showed improved pharmacokinetics (PK). NIM-1324 is also the first and only drug to take a systemic approach to Treg activation, targeting extraintestinal manifestations of disease, combining gut-localized activity and systemic immunoregulatory effects through activation of the LANCL2 pathway to manage symptoms inside and outside the gut.

“Through its unique and clinically validated novel mechanism of action, NIM-1324 selectively enhances anti-inflammatory responses that safely support clinical remission and mucosal healing, as opposed to current IBD treatments that broadly suppress the immune system and result in significant adverse side effects,” Dr. Bassaganya-Riera added. “Importantly, NIM-1324 follows a well-established regulatory path as a safe, effective and convenient oral drug candidate in UC, Crohn’s disease, and other inflammatory and autoimmune diseases. A uniquely differentiated advantage is that NIM-1324’s better drug performance will extend and maximize the LANCL2 therapeutic efficacy and safety both inside and outside the gut, which is critical for providing symptom-free relief and improvements in a wide range of conditions of a growing number of patients with extraintestinal manifestations.”

The launch of NIM-1324’s first-in-patient UC study follows several notable successes across the extensive portfolio of immunoregulatory therapeutic assets that Dr. Bassaganya-Riera’s team has discovered and developed from the ground up. These assets are designed to activate the LANCL2 pathway, which enhances immunoregulatory processes that provide protection from inflammatory and autoimmune diseases. Landos Biopharma, a company founded by Dr. Bassaganya-Riera in 2017, through which he advanced multiple drug candidates targeting novel mechanisms of action into clinical development and completed a successful IPO, was acquired by AbbVie in 2024.

About NImmune Biopharma

NImmune is a private late-stage precision inflammation and immunology (“I&I”) biopharmaceutical company that leverages a proprietary A.I. platform to rapidly and capital efficiently develop novel best-in-class biomarker-driven immunoregulatory therapeutics for inflammatory and autoimmune diseases. Underpinned by the TITAN-X computational platform that utilizes advanced A.I., advanced computational modeling, and bioinformatics and biomedical research capabilities to pioneer innovation in the development and commercialization of novel best-in-class I&I therapies, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates to New Drug Application (NDA) filing and commercialization. Additional information: www.NIMMUNEBIO.COM.

About NIMML

The NIMML Institute is a 501 (c) (3) non-profit foundation dedicated to combining advanced computational modeling using A.I. with translational research and clinical testing to accelerate development of the next wave of precision medicines for inflammatory and autoimmune diseases. The NIMML Institute applies its TITAN-X advanced A.I.-powered platform to large-scale transdisciplinary projects aimed at solving important public health problems through precision medicine. The Institute is headquartered in Blacksburg, VA. For more information, please visit www.NIMML.org.

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