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InDex Pharmaceuticals announces new scientific data


InDex Pharmaceuticals Holding has announced new scientific data on the mechanism of action of cobitolimod, the company’s lead drug candidate.

The findings show that cobitolimod can modulate the immune system in ulcerative colitis by balancing the mucosal Th17/Treg cell response.

Cobitolimod has demonstrated clinical efficacy and a favourable safety profile in inducing clinical remission in patients with active ulcerative colitis. Ulcerative colitis is a chronic disease caused by inflammation of the large intestine. Accumulating evidence indicates that an imbalance between T helper 17 (Th17) and T regulatory (Treg) cells and their associated cytokines promotes a pro-inflammatory state in ulcerative colitis. To further investigate cobitolimod’s mechanism of action, its immunomodulatory effects were analysed in an experimental colitis model and in blood and tissue samples of ulcerative colitis patients.

Treatment with cobitolimod demonstrated therapeutic efficacy in the standard experimental model of colitis. At the same time, Th17 cells and pro-inflammatory IL-17 and IL-6 cytokines were significantly decreased after cobitolimod treatment. In line with these data, cobitolimod significantly decreased IL-17 and significantly increased the anti-inflammatory IL-10 expression in immune cells from ulcerative colitis patients in vitro. Furthermore, analysis of colon biopsies of ulcerative colitis patients taken before and four weeks after administration of cobitolimod showed a significant induction of IL-10 positive and a pronounced reduction of IL-17 positive immune cells after cobitolimod treatment, which was not observed in placebo treated patients. In addition, Treg cells were significantly increased in the colon upon treatment with cobitolimod.

These data were obtained in collaboration with the University of Erlangen-Nürnberg in Germany.

“With these new interesting data we have gained a deeper understanding of how cobitolimod mediates its anti-inflammatory effects,” said Professor Raja Atreya of the University of Erlangen-Nürnberg. “By balancing the Th17/Treg cell immune response, cobitolimod addresses new therapeutic targets in the immunopathogenesis of ulcerative colitis.”

“This supporting mechanistic data is a valuable complement to the clinical findings with cobitolimod,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “The Th17/Treg pathway is currently attracting a lot of interest from the pharmaceutical industry as a promising avenue for intervening in various autoimmune and inflammatory diseases, including inflammatory bowel disease.”