InDex Pharmaceuticals today presents positive results of its lead drug candidate Kappaproct (cobitolimod) to treat moderate to severe active ulcerative colitis (UC) during the Digestive Disease Week congress now underway in Chicago.
The Swedish company said in a press release that it is presenting two posters showing that the drug induces remission of UC symptoms.
Kappaproct (cobitolimod) binds to the toll-like receptor 9 (TLR9), which enhances its function and leads to production of anti-inflammatory cytokines which help reduce inflammation and heal mucosal wounds. TLR9 is crucial in protection against intestinal damage and for intestinal repair.
The first poster, “Binding properties of human TLR-9 receptor to cobitolimod – a candidate for treatment of active Ulcerative Colitis in late stage of clinical development,” shows the binding affinity of cobitolimod to TLR9.
The second, “IL-10 induction properties of the TLR-9 agonist cobitolimod – a candidate for treatment of active Ulcerative Colitis in late stage of clinical development,“ shows that the drug can induce a dose-dependent release in vitro of the anti-inflammatory cytokine IL-10 from immune cells obtained from both healthy individuals and UC patients.
The COLLECT (NCT01493960) trial tested Kappaproct in a placebo-controlled, double-blind, randomized Phase 3 clinical trial that evaluated its effectiveness and safety in 131 chronic active UC patients who had not responded to available therapy. Patients in COLLECT — which took place at 38 sites in seven European countries — received either 30 mg of Kappaproct or a placebo in two separate rectal doses at the study’s start and at week four. The resulting study, “Clinical effects of a topically applied Toll-receptor 9 agonist in active moderate to severe ulcerative colitis,” appeared in the Journal of Crohn’s and Colitis.
The data demonstrated that at week four, 32.1 percent of patients treated with the drug achieved symptomatic remission (absence of blood in stool and weekly stool frequency of less than 35), compared to 14 percent for placebo. At week eight, the proportion was 44.4 percent versus 27.9 percent.
Also at week four, 34.6 percent of patients on Kappaproct had mucosal healing, compared to 18.6 percent for placebo, while 30.9 percent saw histiological improvement in the Geboes score, versus 9.3 percent of placebo patients. The data also showed, at week four, that 21 percent of patients treated with Kappaproct were in clinical remission with mucosal healing, compared to 4.7 percent on placebo. The drug was well tolerated and no major treatment-related adverse effects were reported.
InDex also presented results at February’s European Crohn’s and Colitis Organisation (ECCO) Congress in Barcelona. In November 2016, Index received a U.S. patent covering the use of certain dosage regimens of Kappaproct to treat moderate to severe active ulcerative colitis (UC) in patients not responding to available therapies.
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