InDex Pharmaceuticals develops companion diagnostic test for new ulcerative colitis therapy.

Stockholm, March 20, 2012 – 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.

“InDex Pharmaceuticals is dedicated to personalized medicine. The development of our companion diagnostic test will ensure that the patients treated with Kappaproct are most likely to respond to the drug. Treating only those individuals who are likely to benefit, will increase patient safety, improve outcomes and lower healthcare costs,” said Jesper Wiklund, CEO of InDex Pharmaceuticals.

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).

About Ulcerative Colitis
Ulcerative colitis 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 exists for patients with severe UC. Many of these severe cases have failed all available pharmaceutical therapies. For those patients, surgical removal of the colon by partial or complete colectomy is currently the only remaining treatment option.