Moderate to severe Ulcerative Colitis (UC) can be extremely painful and quite difficult to treat. Patients who do not respond to conventional or biological treatments often find there aren’t many additional options. So researchers are pushing to find new therapies to give them some relief. One of the newest medications in the arsenal is a DNA-based immunomodulatory sequence (DIMS) medication called cobitolimod.
What is cobitolimod and how does it work?Also known as Kappaproct® and DIMS0150, cobitolimod is a new type of medication known as a DIMS. It works by binding to a receptor on immune and epithelial cells in the large intestine. The process triggers the cells to produce anti-inflammatory cytokines. The medication provides a local anti-inflammatory effect when given as a rectal suppository.
What is the COLLECT study?
Published in the Journal of Crohn’s and Colitis in May of 2016, the COLLECT study looked at 131 patients with moderate to severe active UC who had not responded to other therapies. Patients received either 30 mg of cobitolimod (or placebo) as single dosages given rectally at both week zero and week four of the trial.
While the participants were unable to achieve the goal of the clinical remission of disease, there were significant improvements. Symptomatic remission (normal stool frequency without bleeding) was seen in 32 percent of the patients, compared to 14 percent in the placebo group. Registration remission (symptom free with mucosal healing) was seen in 21 percent of cobitolimod patients compared to 4.7 percent in the placebo group.
When would this medication be indicated?
The medication is indicated for those patients with moderate to severe UC that have not gotten adequate relief from other therapies.
Are there side effects to this treatment?
Participants in the COLLECT trial showed no significant side effects compared with the control group. Cobitolimod was found to be well-tolerated and there were no safety concerns observed during the study. Further studies are coming.
When will this medication be available?
Cobitolimod is still in the trial stages. InDex just received permission from the Food and Drug Administration (FDA) to initiate a phase IIb “dose-finding study.” It will aim to determine exactly what dose regimen should be used to optimize the treatment for UC patients.
**While not perfect, the additional of cobitolimod to UC treatments shows great promise to reduce symptoms and improve the patient’s quality of life.
Jennifer has a bachelor's degree in dietetics as well as graduate work in public health and nutrition. She has worked with families dealing with digestive disease, asthma and food allergies for the past 12 years. Jennifer also serves on the Board of Directors for Pediatric Adolescent Gastroesophageal Reflux Association (PAGER).