NIMML Announces Positive Results of Omilancor Clinical Trials in Ulcerative Colitis and Crohn’s Disease at the American College of Gastroenterology 2023 Annual Scientific Meeting

Once-a-day oral dosing with omilancor induced clinical remission in 30.4% of active Ulcerative Colitis (UC) patients versus 3.7% in the placebo group (Δ=26.7%, P = 0.01)

Once-a-day oral dosing with omilancor in active Crohn’s disease (CD) patients shows promising efficacy in preliminary data with placebo-adjusted clinical remission of 32.6%

TITAN-X, proprietary A.I.-powered discovery platform generated highly predictive gene-based biomarkers to enable identification of likely omilancor responders in IBD

Blacksburg, VA, October 23, 2023 – The NIMML Institute (“NIMML”), a 501 (c)(3) nonprofit public charity organization dedicated to the discovery of novel immune-mediated precision medicines, today announced that three abstracts on novel positive clinical data of the clinical development of omilancor, a once-daily oral therapeutic designed to pharmacologically activate the LANCL2 pathway and to create a favorable regulatory microenvironment in the gut, as well as further development in understanding ulcerative colitis (UC) and Crohn’s disease (CD). The abstracts will be presented at the upcoming American College of Gastroenterology (ACG) 2023 Annual Scientific meeting taking place from October 20-25, 2023, at the Vancouver Convention Center in Vancouver, Canada.

Dr. Josep Bassaganya-Riera, President & CEO, said, “Final and complete Phase 2 data for omilancor in mild to severe UC patients with active disease affirms best in class efficacy and unrivaled safety. Omilancor is a first-in-class wholly-owned therapeutic, developed with the guidance of TITAN-X, a proprietary computational modeling and AI-powered precision medicine discovery engine that efficiently accelerates biomarker-driven immunoregulatory therapeutic development of omilancor, NIM-1324 and our other immunoregulatory therapeutics. Meeting the primary endpoint of clinical remission in UC patients with active disease substantially de-risks omilancor’s regulatory path to New Drug Application and provides clinical validation of the LANCL2 pathway as a novel mechanism of action for addressing the significant unmet clinical needs of patients with autoimmune diseases. These positive clinical findings further underscore the power of our advanced computational modeling and A.I.-powered TITAN-X precision medicine platform, which efficiently accelerates biomarker-driven immunoregulatory therapeutic development of omilancor, NIM-1324 and our other immunoregulatory therapeutics.”

“As we approach a significant milestone—the initiation of the pivotal global Phase 3 clinical program of omilancor for the treatment of UC by year-end 2023—we are pleased to present our results at ACG 2023 and encouraged by the continued scientific validation of our clinical findings and the overall momentum of omilancor’s clinical and regulatory development. We look forward to continuing to realize the significant potential of omilancor to be the first-in-class LANCL2 agonist for UC and additional autoimmune indications including Crohn’s disease and psoriasis.”

Presentation Details

Title: Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients with Ulcerative Colitis.

Poster: Board Number P2216, Monday October 23rd, 2023, 10:30 AM – 4:15 PM

Title: Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients with Crohn’s Disease.

Poster: Board Number P2215, Monday October 23rd, 2023, 10:30 AM – 4:15 PM

Title: Transcriptional Analysis of Colonic Biopsies from Patients with Ulcerative Colitis Treated with Omilancor.

Poster: Board Number P2217, Monday October 23rd, 2023, 10:30 AM – 4:15 PM

The posters will be available under the “Publications” section of the NIMML’s website at and at the ACG 2023 ePoster Hall during and after the meeting. Additionally, the peer-reviewed accepted abstracts will be published verbatim in a special supplement to the October 2023 issue of The American Journal of Gastroenterology.

About Ulcerative Colitis (UC)

UC is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation, and ulcers in the lining of the large intestine (colon) and rectum. Symptoms include abdominal pain, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss, and malnutrition. Having UC puts a patient at increased risk of developing colon cancer. Diagnosis typically occurs in early adulthood and the disease requires maintenance treatment for the remainder of the patient’s life. UC is estimated to affect over 900,000 patients in the United States and over 1 million patients throughout the rest of the world. With 70% of addressable patients experiencing a second flare within one year and 30% of patients in remission failing to stay in remission for more than one year, there is an unmet medical need in UC for safer and more efficacious therapeutics.

About Crohn’s Disease (CD)

CD is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation and ulcers in any segment of the gastrointestinal tract. CD impacts the end of the small bowel and beginning of the colon most commonly, which in turn can lead to symptoms of abdominal pain, increased abdominal sounds, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss and malnutrition. There are four classes of CD and treatment depends on the level of severity. Current therapeutic options for severe disease, primarily biologics, have several limitations, which include but are not limited to safety risks for malignancies and infections, limited efficacy and lack of long-term maintenance options. There is an urgent need to establish a consensus for a first-line therapy for CD and improve upon the existing constraints in administration and efficacy.

About Omilancor

By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is a first-in-class, oral, once-daily, gut restricted therapeutic designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory functions in regulatory T cells (Treg) within the site of inflammation. Omilancor has completed Phase 2 clinical testing in UC patients showing a clinical remission of 30.4% with a placebo-adjusted 12-week clinical remission rate of 26.7% (p=0.01) for the 440 mg dose. Following demonstration of a statistically significant approvable primary endpoint for clinical remission in an active disease patient population, NImmune expects to initiate a global pivotal Phase 3 program (PACIFY I and PACIFY II trials) in UC patients in the second half of 2023.

About NIM-1324

NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with NIM-1324 has reduced the production of interferon alpha in human peripheral blood mononuclear cells (PBMCs) from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus, rheumatoid arthritis and multiple sclerosis. Phase 2-ready NIM-1324 completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation.

About NImmune Biopharma

NImmune is a late-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s internal discovery platform is omilancor, a wholly-owned Phase 3 oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis, with fast follower potential in Crohn’s disease, Psoriasis and other autoimmune diseases. Phase 2 first-in-patient data for omilancor in UC show potential best in class efficacy and safety. Additional information: www.NIMMUNEBIO.COM or contact


The NIMML Institute is a 501 (c) (3) non-profit foundation focused on applying transdisciplinary, team-science approaches to precision medicine. 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. NIMML combines the expertise of immunologists, computational biologists, toxicologists, computational modelers, translational and clinical researchers, and molecular biologists to translate novel scientific discoveries into medicines for human diseases. The Institute is headquartered in Blacksburg, VA. For more information, please visit or contact

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