NImmune Biopharma Unveils Superior Efficacy and Safety of Omilancor in IBD at DDW 2025, Outperforming Leading Anti-TL1A Treatments

NImmune Biopharma, a private biopharmaceutical company specializing in precision inflammation and immunology (I&I), will present groundbreaking head-to-head clinical and translational results at Digestive Disease Week 2025 (DDW'25). These findings compare omilancor, a first-in-class LANCL2 agonist, to the leading anti-TL1A candidate, both in Phase 3 development, for treating ulcerative colitis (UC). Key Findings The clinical research presented at DDW'25 shows that omilancor, an oral medication taken once daily, significantly outperformed the leading anti-TL1A antibody and placebo in reducing disease activity in patients with active UC. Specifically, omilancor induced clinical remission in 30.4% of active UC patients and 33.3% of biologic-refractory UC patients at a dose of 440 mg/day. Importantly, omilancor's efficacy was evident within just two weeks of treatment, demonstrating its rapid action. In addition to its superior clinical performance, omilancor has an unrivaled safety profile. Multiple clinical studies have confirmed that the drug does not cause any identifiable treatment-related adverse events, making it an attractive option for long-term use. Omilancor also addresses underlying immunometabolic dysfunctions, reversing colonic regulatory T-cell (Treg) depletion and mitochondrial dysfunction in severe UC patients. These mechanisms define a critical subset of patients who are often unresponsive to existing treatments but highly responsive to LANCL2 drugs. Development and Technology NImmune's success with omilancor is driven by its proprietary TITAN-X Precision Medicine Platform, a cutting-edge AI tool that integrates advanced computational modeling, bioinformatics, and clinical data analysis. The platform was used to analyze global transcriptomics datasets from colonic biopsies of UC patients and to perform computational simulations of the effects of LANCL2 and anti-TL1A in immunometabolism. This comprehensive approach has not only accelerated the development of omilancor but also ensured that it targets the most relevant biological pathways and patient subpopulations. CEO’s Perspective Dr. Josep Bassaganya-Riera, Founder and CEO of NImmune Biopharma, emphasized that the company’s goal with omilancor is to break through the treatment ceiling in IBD. He noted that despite numerous FDA-approved treatments and combination therapies, there remains a significant unmet clinical need for novel, highly effective treatments that can help patients with severe and resistant conditions. Bassaganya-Riera highlighted that omilancor's combination of unparalleled safety, best-in-class efficacy, and convenient once-daily oral dosing makes it an ideal backbone therapy for UC and other I&I indications. Future Directions NImmune is advancing omilancor through its Phase 3 clinical trials for UC and has plans to initiate regulatory filings upon successful completion. The company is also evaluating omilancor for Crohn’s disease and other inflammatory and autoimmune conditions, positioning it as a versatile treatment option. The mounting clinical and translational evidence supports a clear path to commercialization, addressing the urgent needs of patients from mild to severe cases. Industry Evaluation Industry insiders have been particularly impressed by the comprehensive nature of NImmune’s approach. The use of AI and advanced computational modeling to identify and validate targets, along with the robust clinical trial data, sets a new standard for precision medicine in I&I. The favorable safety profile and significant improvement in patient outcomes suggest that omilancor could disrupt the current treatment landscape for UC and other IBDs. Company Profile NImmune Biopharma is headquartered in Blacksburg, VA, and focuses on developing novel, biomarker-driven immunoregulatory and immunometabolic therapies. The company’s lead candidate, omilancor, targets LANCL2 for UC and has demonstrated best-in-class efficacy and safety. NImmune’s business model emphasizes rapid and capital-efficient clinical development, aiming to bring high-impact therapies to market quickly. About the TITAN-X Platform The TITAN-X Precision Medicine Platform is a critical component of NImmune’s pipeline. It uses AI methodologies to analyze differentially expressed genes and integrate clinical data, identifying transcriptional predictive signatures and responder patterns. This precision medicine approach ensures that patients receive the most appropriate and effective treatments based on their unique genetic and clinical profiles, enhancing both safety and efficacy. Conclusion NImmune Biopharma’s upcoming presentation at DDW'25 is expected to generate significant interest among researchers and clinicians. The head-to-head trial results not only highlight the potential of omilancor to become a leading treatment for severe UC but also underscore the power of AI in drug development. As more data becomes available, the biopharma company is well-positioned to meet the pressing needs of IBD patients and pave the way for future advancements in precision medicine.