MediGene Initiates Clinical Formulation Study of RhuDex for the Oral Treatment of Autoimmune Diseases

01-27-2012: MediGene AG continues clinical development of its drug candidate RhuDex® by initiating a clinical formulation study. The trial objective is to develop an optimized oral formulation of the active substance suitable for the treatment of chronic diseases. The results of this formulation study are expected midyear 2012.

Dr. Frank Mathias, CEO of MediGene AG, comments: "The initiation of this formulation study is an important step in the development of this innovative drug candidate. We developed an optimized formulation concept which, in the case of successful clinical testing, will add a significant competitive advantage to RhuDex®."

Previous preliminary formulations of RhuDex® permitted initial clinical trials of the drug candidate. For the long-term development and subsequent marketability of the product, MediGene seeks an improved oral formulation and dosage form of RhuDex® to facilitate a therapeutically ideal release of the active ingredient, as well as a patient-friendly dosing regimen.

During the formulation study, a single dose of RhuDex® will be administered orally to up to twelve volunteers. Based on the innovative RapidFACTTM (Rapid Formulation Development and Clinical Testing) study design, variants of formulations can be tested over a short period because the trial medication is produced immediately prior to dosing. This approach facilitates a fast and cost-efficient execution of the trial.