Project Grant R44DK148208

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Op-T-Mune, Inc. $635,040 on September 1, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to conduct a Phase 2A clinical trial of OPT101, a CD40-targeting peptide for type 1 diabetes mellitus.

OPT101 is a 15-amino-acid peptide derived from CD154 protein that targets CD40 on pathogenic T cells (TH40 cells) with specificity conferred through integrin association. The therapeutic approach aims to selectively eliminate autoinflammatory effector cells while sparing bystander T cells involved in normal immunity, addressing limitations of existing monoclonal antibody treatments. Preclinical work in NOD mice showed OPT101 prevented diabetes onset and reversed hyperglycemia in 57 percent of diabetic mice, with substantial improvements in overall health and life expectancy. In a veterinary pilot study, OPT101 treatment increased time in normal blood glucose range from 10 percent to over 80 percent in diabetic dogs and reduced daily insulin requirements by up to 90 percent. Phase 1A testing in healthy volunteers and Phase 1B testing in type 1 diabetic subjects aged 2 to 20 years post-diagnosis demonstrated safety and tolerability at doses of 1.1 and 2.8 milligrams per kilogram. FDA granted safe-to-proceed authorization for human clinical trials.

The award period runs through August 31, 2029, with place of performance in Aurora, Colorado.