Swedish Biotech gets Orphan Drug Designation in Pediatric Colitis
InDex Pharmaceuticals has gotten a boost from the FDA for cobitolimod, which is in Phase II for the treatment of pediatric ulcerative colitis.
Stockholm-based InDex Pharmaceuticals is working on treatments for ulcerative colitis based on toll-like receptors (TLRs), the subject of 2011 Nobel Prize in Medicine. Its lead candidate for moderate to severe ulcerative colitis, cobitolimod, has just received Orphan Drug Designation from the FDA in the treatment of children taking the company in a new direction.
Cobitolimod is InDex’s only clinical-stage asset, with two more for “inflammation” in preclinical development. Index has focused its efforts on developing TLR9 agonists that mimic bacterial DNA to stimulate the production of anti-inflammatory cytokines by immune cells. Targeting TLRs also underpins Mologen’s efforts in HIV and Riboxx‘s vaccines for cancer and infections, as well some approaches to multiple sclerosis.
Editor’s Note: Pediatric ulcerative colitis is not the main target indication for cobitolimod, and no trials have been conducted for this patient category.
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