The company’s lead pharmaceutical product Kappaproct^®, approved for Orphan Drug Designation in Europe, has completed its third clinical phase II trial for the treatment of steroid resistent/dependent ulcerative colitis patients. A study to amplify steroid effect in reducing intracranial edema in brain tumor patients is in planning.

The specific Kappaproct cytokine/chemokine induction characteristics confirm what has been reported in scientific publications in terms of using interferons and other naturally occurring proteins to amplify the effect of steroid treatment (more precisely glucocorticosteroids, GCS). These findings have been further supported in a screening program of a series of genetic markers in human blood that are influenced by the status of a patient’s responsiveness to steroid treatment.

Kappaproct is currently approved for use in clinics as a rectal, single-dose administration. Qualification of the compound for other routes of administration and multiple dosing is underway through extended tox programs and of great importance for the continued development work in other clinical indications such as brain tumor and hematological malignancies. So far, more than 160 patients have been dosed with Kappaproct with solid safety data.

Further confirmation that Kappaproct can re-sensitize non-responding patients to steroids, such that long term steroid free remission can be achieved, is expected to open up for broader applications in other types of chronic inflammation, e g airway inflammations like asthma and COPD.