NImmune Biopharma will present groundbreaking head-to-head clinical and translational data at Digestive Disease Week 2025, demonstrating that its novel oral therapy omilancor outperforms leading anti-TL1A antibodies in treating inflammatory bowel disease (IBD).
The studies, scheduled for presentation at the San Diego Convention Center from May 3-6, reveal that omilancor—a once-daily, oral, first-in-class LANCL2 agonist—significantly ameliorates disease activity compared to anti-TL1A antibody treatments and placebo in ulcerative colitis patients.
Superior Efficacy with Unmatched Safety Profile
Omilancor demonstrated remarkable consistency across multiple clinical studies, achieving clinical remission in 30.4% of active ulcerative colitis patients and 33.3% of biologic-refractory patients at the designated Phase 3 dose of 440 mg/day.
"We created omilancor to be a unique, best-in-class oral therapy that can break through the treatment ceiling in IBD," said Dr. Josep Bassaganya-Riera, Founder and CEO of NImmune Biopharma. "Hence, we are not surprised by omilancor's remarkable consistency across multiple clinical studies as a best-in-class efficacy with unrivaled safety with no dose-limiting toxicities."
The drug outperformed anti-TL1A antibodies on histological measures and in downregulating inflammatory genes implicated in neutrophil recruitment and activation, including Cxcl5, as well as genes typically associated with increased disease severity in IBD and gut mucosal inflammation.
Multiple clinical studies have confirmed omilancor's safety profile with no identifiable treatment-related adverse events—a significant advantage over existing therapies.
Novel Mechanism Addresses Treatment-Resistant Patients
One of the most promising aspects of omilancor is its ability to reverse colonic regulatory T-cell (Treg) depletion and mitochondrial dysfunction in severe ulcerative colitis patients. This mechanism specifically targets a core subset of patients traditionally refractory to existing approved IBD treatments.
The therapy's development leveraged NImmune's proprietary TITAN-X AI Precision Medicine Platform, which combines advanced computational modeling with translational research to accelerate precision medicine development.
"Despite a multitude of FDA-approved treatments and the emergence of combination treatments for UC and CD, there remains a significant unmet clinical need for novel treatments that can induce and maintain significant improvements in clinical remission and break the efficacy ceiling of current therapies," Dr. Bassaganya-Riera explained.
Path to Commercialization
Currently in Phase 3 clinical development for ulcerative colitis and Phase 2 for Crohn's disease, omilancor is positioned to address multiple inflammatory and autoimmune indications.
NImmune Biopharma plans to complete Phase 3 development of omilancor in ulcerative colitis and initiate a New Drug Application (NDA) with the U.S. FDA by 2027, with additional NDAs to follow.
The company believes omilancor's combination of efficacy, safety, and convenient once-daily oral dosing makes it an ideal backbone therapy for ulcerative colitis and potentially other inflammatory conditions.
Upcoming Presentations at DDW 2025
Two key presentations at Digestive Disease Week will showcase omilancor's clinical advantages:
Research Forum Oral Presentation:
- Title: "Oral Omilancor Treatment Outperforms Anti-TL1A Therapeutics in IBD"
- Time: Monday, May 5, 9:00-9:15am PT
Poster Session Presentation:
- Title: "Omilancor Reverses Colonic Treg Depletion and Downregulation of Mitochondrial Metabolism in Severe Ulcerative Colitis Patients"
- Time: Sunday, May 4, 12:30-1:30pm PT
Complementary Mechanisms
The research also highlights potential synergies between omilancor and anti-TL1A therapies. While omilancor outperforms anti-TL1A as a standalone treatment, the studies suggest complementarity between LANCL2 and TL1A mechanisms of action in IBD, potentially opening the door for future combination therapies.
This research represents a significant advancement in IBD treatment options, particularly for patients who have failed to respond to current therapies. With its novel mechanism of action, strong safety profile, and oral administration, omilancor could potentially transform the treatment landscape for inflammatory bowel diseases.
