Tag: COLLECT study

Company News: InDex Pharmaceuticals Develops Companion Diagnostic Test for New Ulcerative Colitis Therapy

– Personalized treatment option for patients with refractory ulcerative colitis –

InDex Pharmaceuticals today announced the development of a companion diagnostic test for Kappaproct®. Kappaproct, the lead product candidate of InDex, is currently in a phase III study as a treatment for chronic active, treatment refractory ulcerative colitis. In this study, the companion diagnostic test is being evaluated to demonstrate a correlation between test result and clinical response to Kappaproct.

In previous clinical trials, Kappaproct has shown positive effects for the treatment of steroid resistant ulcerative colitis patients. The companion diagnostic test aims to enable the pre-selection of steroid resistant patients that are most likely to benefit from Kappaproct. The proprietary in vitro test is based on a number of biomarkers and is performed on a blood sample prior to administration of Kappaproct.

A companion diagnostic is designed to assess whether a patient will respond favorably to a specific medical treatment or not. Companion diagnostics are a crucial element of personalized medicine, which is becoming increasingly important along with the demand for safer and more efficacious medicines. Companion diagnostics also reduce healthcare costs as the use of ineffective therapies can be avoided.

In 2009, InDex Pharmaceuticals launched the diagnostic test DiBiCol® in Sweden. DiBiCol differentiates between ulcerative colitis (UC) and Crohn’s disease (CD), the two major forms of inflammatory bowel disease (IBD).

Company News: InDex Pharmaceuticals Starts Phase III COLLECT Study with Kappaproct®

– TLR9 Agonist for the Treatment of Chronic, Active, Treatment-Refractory Ulcerative Colitis –

InDex Pharmaceuticals today announced the start of the COLLECT trial, a European multicenter Phase III study to evaluate the effectiveness and safety of Kappaproct for the treatment of chronic active ulcerative colitis (UC) patients not responding to available therapy. Kappaproct is a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9).

UC is a chronic, relapsing-remitting disease caused by inflammation of the colon. Although current UC treatments are effective for many patients with mild to moderate disease, a significant unmet medical need still exists for patients with severe UC. Many of these patients have failed all available pharmaceutical therapies – therefore, surgical removal of the colon by partial or complete colectomy is currently the only remaining treatment option.

The primary endpoint of the COLLECT study is induction of clinical remission in these severe UC patients, who have failed all other medical treatments and have been elected for colectomy. Preliminary results are expected for Q1, 2014.

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