NImmune reports that omilancor reduced a biologic-refractoriness gene signature by over 55% in 12 weeks, alongside preclinical findings in IBD and C. difficile models.
Written By: Aasritha Thippavajjala, PharmD
Reviewed By: Pharmacally Editorial Team
NImmune Biopharma reported clinical and preclinical findings from two presentations at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting. In the clinical presentation, omilancor reduced a 78-gene expression signature associated with biologic refractoriness by more than 55% from baseline after 12 weeks of treatment in patients with ulcerative colitis (UC) and Crohn’s disease (CD). A separate preclinical study evaluated omilancor and NIM-1324 in models of co-occurring inflammatory bowel disease (IBD) and Clostridioides difficile infection (CDI).
Omilancor Reduces a 78-Gene Refractoriness Signature
Investigators evaluated a 78-gene signature associated with inflammation and nonresponse to multiple classes of biologic therapies. After 12 weeks of oral omilancor treatment, the overall signature score decreased by more than 55% from baseline, while the expression of genes associated with biologic refractoriness fell by more than two-fold on average.
These findings indicate a change in a molecular signature associated with treatment refractoriness. However, they do not establish that omilancor reverses clinical resistance, prevents treatment failure or improves long-term disease control.
NImmune also reported that patients with prior biologic exposure experienced clinical, symptomatic and endoscopic remission at rates similar to those in the overall and biologic-naive populations. However, the announcement does not provide numerical remission rates, confidence intervals or statistical comparisons, limiting independent assessment of these observations.
The company also did not disclose the trial identifier, participant numbers, treatment dose, comparator details, analysis population or statistical methods. These omissions limit assessment of the magnitude and reliability of the findings and whether the molecular changes correspond to meaningful clinical benefits.
Preclinical Findings in IBD and C. difficile Infection
The second presentation, titled “NIM-1324 Activates LANCL2 to Reduce Recurrence and Disease Severity in IBD and Clostridioides difficile Infection Co-occurrence Models,” evaluated both medicines in preclinical models.
According to NImmune, omilancor and NIM-1324 reduced weight loss, disease activity, intestinal pathology and recurrent bacterial burden while improving survival in the experimental models. Oral treatment also maintained regulatory immune responses and supported greater gut microbiome diversity, including an increased abundance of beneficial commensal bacteria associated with protection against infection.
These findings suggest potential activity in experimental IBD and CDI co-occurrence models. However, they do not establish that either medicine reduces infection severity, prevents recurrence or improves survival in patients.
LANCL2 Development Programme and Evidence Limitations
NImmune describes omilancor and NIM-1324 as oral, once-daily LANCL2-targeting medicines in development for inflammatory and autoimmune diseases. Both are being developed using the company’s TITAN-X platform, which combines artificial intelligence, computational modelling, bioinformatics and mechanistic research.
NImmune’s chief executive, Dr Josep Bassaganya-Riera, said the findings support the potential of LANCL2-targeting medicines to alter biological processes associated with treatment refractoriness and reduce infection risk.
However, the reported gene-expression changes do not establish improved clinical outcomes, and the infection-related findings remain preclinical. The announcement also lacks detailed safety results and comparative clinical infection rates, preventing independent assessment of tolerability and infection risk.
Clinical Significance: What Needs to Be Established
The greater-than-55% reduction in the gene-expression signature is the principal quantitative finding from the clinical presentation. Its clinical significance will depend on whether the change correlates with established outcomes, including remission, and whether it can help predict treatment response in patients with prior biologic exposure.
The remission observations in previously treated patients are relevant to difficult-to-treat IBD, but the absence of numerical results and statistical comparisons prevents conclusions about comparative efficacy. Further clinical data are needed to determine whether the molecular changes translate into sustained clinical benefit and to characterize safety.
Overall, NImmune’s ACG 2026 findings provide preliminary clinical evidence of a change in a gene-expression signature associated with biologic refractoriness, alongside supportive preclinical findings for two LANCL2-targeting medicines. Detailed clinical results will be necessary to establish the relationship between these molecular changes, remission outcomes and meaningful treatment benefit.
Reference
NImmune Biopharma Presented New Data at ACG 2026 Supporting the Efficacy and Safety of Innovative LANCL2 Medicines Targeting a Novel Mechanism in Hard-to-Treat IBD, NImmune Biopharma, 13 October 2026
About the Writer
Aasritha Thippavajjala (Linkedin) is a pharm D student and aspiring medical writer with medical writing, clinical training experience and a strong interest in clinical research and patient safety She has hands-on exposure to clinical pharmacy activities including medication profile assessment, clinical case review, identification of potential drug-related problems, ADR awareness, patient counselling, and clinical documentation. She has also gained experience in medical literature review, evidence synthesis, and scientific communication through her published review article on digital twin-based patient simulation and her poster presentation at the 74th Indian Pharmaceutical Congress. Certified in ICH Good Clinical Practice (E6(R3)) and Scientific Writing in Health Research, she is passionate about applying her clinical knowledge and research skills to medical writing ,clinical research and contributing to accurate, evidence-based healthcare.
