NImmune Biopharma, a late-clinical-stage biopharmaceutical company, has presented promising Phase 1 clinical results for NIM-1324, an oral, once-daily LANCL2 agonist therapeutic aimed at treating rheumatic diseases, specifically systemic lupus erythematosus (SLE). The findings were shared at the American College of Rheumatology’s (ACR) annual meeting, ACR Convergence 2023, in San Diego, California.
Dr. Josep Bassaganya-Riera, Founder and CEO of NImmune, highlighted the significance of these results, stating that NIM-1324 met all primary and secondary endpoints of safety and tolerability in its first-in-human trial for SLE. The therapeutic leverages the LANCL2 pathway, showing no dose-limiting toxicities and offering a novel mechanism of action for SLE treatment. The company anticipates initiating a Phase 2 trial for NIM-1324 in SLE by 2024, with top-line results expected by 2025.
The clinical results of NIM-1324 were developed using the TITAN-X platform, an A.I. discovery and development tool that has guided the development of NImmune’s LANCL portfolio. NIM-1324, along with omilancor, another therapeutic in NImmune’s pipeline, are oral, once-daily therapies that activate the LANCL2 pathway, with NIM-1324 designed for systemic distribution for conditions like lupus and rheumatoid arthritis.
In the Phase 1 study, NIM-1324 demonstrated safety and tolerability across various doses, with no severe adverse effects or significant findings in biochemistry, coagulation, hematology, or urinalysis compared to placebo. The therapeutic also showed a dose-proportional change in plasma exposure and upregulated mitochondrial metabolism genes while downregulating markers of phagocyte activation.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder affecting over 1.5 million patients in the United States and more than 5 million worldwide. It causes systemic inflammation and organ damage, significantly impacting patients' quality of life. The development of NIM-1324 represents a significant step forward in addressing the unmet medical need for safer and more effective SLE therapeutics.
NIM-1324 is an oral, systemically distributed small-molecule therapeutic that activates LANCL2, modulating cellular and molecular changes tied to autoimmune diseases. It has shown promise in reducing interferon alpha production in SLE patients and providing protection in mouse models of lupus, rheumatoid arthritis, and multiple sclerosis.
NImmune Biopharma continues to advance its pipeline of immunoregulatory therapeutics, with omilancor, another LANCL2 pathway activator, also showing positive Phase 2 results for ulcerative colitis (UC). The company's innovative approach, leveraging A.I. and computational modeling, positions it as a leader in the development of precision immunology therapeutics.
