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COLLECT: Cobitolimod Induces Remission in Both Moderate, Severe UC
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Cobitolimod induced clinical remission in patients with both moderate and severe ulcerative colitis, according to data from a post-hoc analysis of the COLLECT study presented at UEG Week 2016.
Cobitolimod (InDex Pharmaceuticals), formerly known as DIMS0150 (Kappaproct), is a novel toll-like receptor 9 (TLR9) agonist that can provide a local anti-inflammatory effect in the large intestine, which can induce mucosal healing and symptom relief in UC, according to a press release from the manufacturer. Previous studies have shown improvements in key clinical UC symptoms like blood in stool, number of stools and mucosal healing.
“The results suggest that cobitolimod can induce clinical remission in patients with both moderate and severe ulcerative colitis. As expected the highest remission rates were obtained in patients with moderate disease activity, which is in line with other therapies in this indication,” Raja Atreya, MD, from the University of Erlangen-Nürnberg, said in the press release. “Cobitolimod is a very promising novel therapeutic option for this debilitating condition and I am now looking forward to start the next larger clinical phase 2b study with cobitolimod.”
Investigators evaluated data on the 131 trial participants recruited from 38 centers across seven countries in Europe. All patients had moderate-to-severe UC who failed conventional therapy and received either cobitolimod or placebo with standard of care treatment.
To evaluate the influence of disease activity on the drug’s efficacy, researchers assessed patients based on baseline disease severity subgroups: 28% had moderate disease, 46% had moderate-to-severe disease and 26% had severe disease.
At week 4, 32% of the patients with moderate disease achieved clinical remission after treatment with cobitolimod compared with 8% of those in the same subgroup who received placebo. In addition, 22% of the patients with moderate-to-severe disease achieved remission at week 4 after treatment with cobitolimod compared with 0% of those in the same subgroup who received placebo. Finally, 9% of the patients with severe disease achieved week-4 remission with cobitolimod compared with 0% of patients in the same subgroup who received placebo.
The researchers also analyzed TNF-experienced (39%) and -naive patients, and found the latter group had higher absolute remission rates, which was expected, according to the press release. Overall, 28% of the TNF-naive patients achieved week-4 clinical remission with cobitolimod vs. 0% of those who received placebo. Among TNF-experienced patients, 10% in the cobitolimod group vs. 6% in the placebo group achieved week-4 clinical remission. – by Adam Leitenberger
Reference:
Atreya R, et al. Presented at: United European Gastroenterology Week; Oct. 15-19, 2016; Vienna.
Disclosures: Healio Gastroenterology was unable to confirm Atreya’s relevant financial disclosures at the time of publication.