The study “Clinical effects of a topically applied Toll- receptor 9 agonist in active moderate to severe ulcerative colitis,” published in the Journal of Crohn’s and Colitis (JCC), investigated the drug’s treatment potential in 131 patients.
The study, called the COLLECT clinical trial, included patients with moderate to severe active ulcerative colitis, and those who responded poorly to conventional therapy. Patients received either 30 mg of cobitolimod or a placebo in two separate rectal doses at the beginning of the study and at week four. The drug was administered in addition to standard therapies.
Cobitolimod functions as a TLR9 agonist, which enhances its function and leads to the production of anti-inflammatory cytokines — agents that play an important role in reducing inflammation and healing mucosal wounds. TLR9, a Toll-like receptor, is important for protection against intestinal damage and for intestinal repair.
The study was conducted across seven European countries at multiple sites, and was funded by the drug’s manufacturer InDex Pharmaceuticals. Cobitolimod is a first-in-class drug.
Although the goal of clinical remission was not reached, patient improvements were significant: a symptomatic remission (normal stool frequency without bleeding) in 32% of the patients compared to 14% in the placebo group; and registration remission (classified as symptom free with mucosal healing) in 21% of cobitolimod patients compared to 4.7% in the placebo group.
The combined score of symptomatic remission and mucosal healing (an endpoint of the trial) was also found significant: 21% reached the endpoint in comparison to the placebo group result of 2.3%.
“In active ulcerative colitis, the goal of treatment is to induce remission characterized by a reduction in stool frequency and blood in stool, accompanied by an improved or normalized endoscopic score. The COLLECT study demonstrates that cobitolimod can achieve these goals, also in patients who are refractory to some currently available treatments,” Hawkey said in a press release.
Additionally, cobitolimod was found to be well-tolerated, with no safety concerns observed during the study.
Peter Zerhouni, CEO of InDex Pharmaceuticals, said the study shows cobitolimod to be a “promising and well-tolerated potential novel therapeutic” against moderate to severe active ulcerative colitis.
“InDex is currently preparing for the next clinical study with cobitolimod, which will be a phase IIb study to optimize the dosing regimen with the goal to provide substantially higher efficacy, while maintaining the compound’s superior safety profile,” Zerhouni said.