InDex Pharmaceuticals Announces Positive Results from a Pharmacokinetic (PK) Study with Cobitolimod

InDex Pharmaceuticals has announced positive results from a pharmacokinetic (PK) study with cobitolimod in patients with moderate to severe ulcerative colitis. The systemic uptake was limited both for patients with active disease and in clinical remission. For the first time patients have been treated with doses of 500 mg, and in line with previous studies cobitolimod was well tolerated.

“One of the potential benefits of a locally acting treatment in the colon is low systemic exposure. We are therefore excited that the study has confirmed this benefit also with the higher dose of 500 mg cobitolimod,” said Jenny Sundqvist, CEO of InDex Pharmaceuticals. “This is the first time that the 500 mg dose of cobitolimod has been administered to patients, and it is reassuring that it was well tolerated. The study is also essential for, and required in, future regulatory applications for market approval.”

The study results include PK data from 7 patients with moderate to severe ulcerative colitis treated with doses of 500 mg of cobitolimod administered rectally. Plasma concentrations of cobitolimod were first measured after administration of 500 mg cobitolimod in all the 7 patients during a flare. The patients were then treated with a second dose of 500 mg cobitolimod at week 3, after which the degree of clinical remission was evaluated at week 6. Even though it was a small-scale open-label study, it was encouraging that 4 out of 7 patients achieved clinical remission at week 6. A second PK-analysis was conducted after these patients had received a third dose of 500 mg cobitolimod. This analysis aimed to investigate the systemic uptake of cobitolimod also in patients with remission.

The results showed a limited systemic uptake following the 500 mg cobitolimod dose both for patients in a flare and in remission, with the majority of patients having undetectable levels of cobitolimod in the plasma after 8 hours. Cobitolimod was well tolerated, and no serious adverse events were reported in the study.