InDex Pharmaceuticals today announced that the last patient has now been recruited to
its clinical Phase II study of Kappaproct, for treating steroid resistant/dependent patients
with ulcerative colitis of mild to moderate degree.
The study is placebo-controlled, randomized and double-blind and evaluates more than
30 patients at centres in Sweden and Russia.
The primary objective is to evaluate the clinical response of Kappaproct given as a single
dose of 30 mg compared to placebo. Patients are monitored for a period of six months
after dosing. The study also includes an evaluation of a biomarker test for steroid
response. By developing a blood sample test for assessing if a patient is likely to respond
to Kappaproct treatment or not – a so called companion diagnostic – InDex follows new
guidelines for personalized medicine.
“We are quite excited about this study. A confirmation that the drug can amplify steroid
response or re-sensitize non-responding patients to steroids can have significant
implications also for other types of chronic inflammation, including asthma and COPD”,
says CEO Svante Rasmuson.