Swedish Ulcerative Colitis Treatment Makes Phase II Comeback

InDex Pharmaceuticals’ ulcerative colitis drug candidate has achieved positive phase IIb results, suggesting work to improve its dosage after a previous phase III failure was successful. 

The Swedish company tested different doses of the small molecule drug cobitolimod against a placebo in patients with the inflammatory bowel disease ulcerative colitis. The 213 patients in the trial hadn’t responded to current treatments for the chronic condition and needed new options. After six weeks of treatment, around 21% of patients given the highest dose were free of ulcerative colitis symptoms, such as diarrhea and having blood in their feces. In contrast, only 6% of the placebo group had this outcome. 

These results show promise for InDex’s drug as an alternative treatment for ulcerative colitis. This lifelong inflammatory bowel condition currently has no cure and is thought to arise when immune cells attack the gut lining. Current treatments such as immunosuppressants aim to clear the symptoms of ulcerative colitis, but the condition often relapses, with the last resort being surgical removal of the colon. 

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Cobitolimod is a first-in-class drug designed to relieve inflammation by binding to the protein Toll-like receptor 9 in cells residing in the gut. This results in the production of proteins that reduce inflammation and relieve the symptoms.

InDex previously tested the same drug in a phase III trial in ulcerative colitis back in 2016, but missed its primary endpoint of clearing the symptoms better than the placebo. After the phase III setback, InDex reported that the placebo group had shown unexpected improvements in that trial, and went back to a phase IIb trial to test a higher dosage. The company hasn’t disclosed when it aims to begin the next phase III trial with the new, higher dose.


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