Results of a clinical trial evaluating Resunab (JBT-101) in a model of inflammation in healthy subjects indicated that this drug may be a treatment for chronic immune responses linked to tissue inflammation and cystic fibrosis (CF).
Researchers administered a subcutaneous injection of a non-active form of the bacteria E. coli to healthy subjects to induce inflammation. The team then measured blood flow to the site of the injection, and took fluid samples at the site to investigate the composition of cells and inflammatory mediators present at different times after the injection. Participants were distributed into three groups of five people each, receiving either Resunab 5 mg, Resunab 20 mg (twice-daily in both cases) or placebo, all of which were given before the procedure.
Results indicated that both doses of Resunab induced a nearly 70 percent reduction in inflammation by inhibiting neutrophil infiltration, a key determinant of inflammation severity, and decreased blood flow around the site of inflammation at four hours after the injection, to also lessen the inflammatory response.
Moreover, the treatment allowed for a progressive increase in blood flow around the site of inflammation during the early phases of resolution (10–24 hours after the injection), indicative of an efficient inflammatory response with timely resolution.
“These are very exciting data,” Gilroy said in a news release. “While conventional immune modulatory agents dampened the signs and symptoms of inflammation, none are curative while most have undesirable side effects; the latter may arise from interfering with the body’s own healing process of resolution.”
And, he added: “With Resunab, we have a drug which is both anti-inflammatory and pro-resolution. We are particularly excited by these findings and to understand the internal signaling systems used by Resunab that exhibits such a favorable result.”
Resunab is currently under evaluation in Phase 2 trials as a treatment for CF and other diseases. The study in CF adults (NCT02465450) is evaluating the safety, tolerability and efficacy of Resunab against placebo at sites across the U.S. and Europe, and is fully enrolled. Top-line results are expected early in 2017.
Resunab is a synthetic oral drug, with a safe and well-tolerated action, that activates a group of proteins called CB2 receptors. These receptors are expressed on immune cells and, when activated, trigger molecular pathways that resolve inflammation and halt fibrosis.