The data will be presented by Raja Atreya, a professor at the University of Erlangen-Nürnberg, during United European Gastroenterology Week (UEGW), Oct. 15-19, in Vienna.
COLLECT (NCT01493960) was a placebo-controlled, double-blind, randomized study that assessed the effectiveness and safety of Kappaproct in 131 chronic active ulcerative colitis patients who had not responded to available therapy. COLLECT was conducted at 38 centers in seven European countries.
Patients received either two single rectal 30 mg doses of Kappaproct or a placebo four weeks apart. They were followed for 12 weeks. The primary endpoint was clinical remission, defined by the Clinical Activity Index (CAI), at week 12. Secondary endpoints included mucosal healing and symptomatic remission (absence of blood in stool and weekly stool frequency of less than 35).
The results supporting Kappaproct as a novel treatment for moderate to severe active UC were recently published in the Journal of Crohn’s and Colitis (JCC), in a study report titled “Clinical effects of a topically applied Toll- receptor 9 agonist in active moderate to severe ulcerative colitis.”
The published data shows statistically significant differences between patients treated with the drug versus those treated with placebo. The proportion of patients who achieved symptomatic remission was 32.1% versus 14% at week 4, respectively, and 44.4% versus 27.9% at week 8, respectively.
In addition, at week 4, more patients treated with Kappaproct compared to placebo had mucosal healing (34.6% versus 18.6%) and histological improvement in the Geboes score (30.9% versus. 9.3%). The data also showed, at week 4, that more patients treated with Kappaproct were in clinical remission with mucosal healing compared to placebo (21% versus 4.7%, respectively). The drug was well tolerated and no major treatment-related adverse effects were reported.
Additional results to be presented at UEGW include that Kappaproct can induce clinical remission in patients with moderate disease and those with severe disease activity.
Atreya’s oral presentation, “Clinical Disease Activity Influences the Therapeutic Efficacy of the Toll-like Receptor 9 Agonist Cobitolimod in Patients with Moderate to Severe Active Ulcerative Colitis,” is set for Oct. 17.
On Oct. 19, he will present the poster “Clinical Efficacy of the Toll-like Receptor 9 Agonist Cobitolimod in Anti-TNF-antibody Treated and Naïve Patients with Moderate to Severe Active Ulcerative Colitis.”
Cobitolimod is a first-in-class toll-like receptor 9 agonist which mimics microbial DNA through immunomodulation. The drug, in late-stage clinical development, provides local anti-inflammatory relief by healing the colonic mucosa.
The World Health Organization (WHO) recommended the name “cobitolimod” in January.
In March, the U.S. FDA cleared InDex Pharmaceuticals’s Investigational New Drug application to launch a Phase 2b clinical trial for Kappaproct in patients with moderate to severe UC. The planned trial will be a dose-finding study to optimize the dose regimen for people with the disease.