Positive results of clinical formulation study enable further clinical development with new, optimized formulation
Phase II proof-of-concept (PoC) study for autoimmune diseases in the indication primary biliary cirrhosis (PBC) planned to start by year-end 2012
PoC study builds basis for further development in rheumatoid arthritis
Martinsried/Munich, June 21, 2012. Medigene AG (Frankfurt, Prime Standard: MDG) announced today that the clinical formulation trial with RhuDex® achieved positive results and that the further clinical development of RhuDex® for the treatment of autoimmune diseases will continue with an optimized oral formulation. As the next development step, Medigene plans to initiate a phase II proof-of-concept study in primary biliary cirrhosis (PBC) before the end of 2012 to verify both the mechanism of action and the overall clinical profile of RhuDex® for the treatment of autoimmune diseases. The study results are expected to build a basis for the further development in rheumatoid arthritis.
Dr. Frank Mathias, CEO of Medigene AG, comments: "Medigene has developed a logical and integrated non-clinical and clinical program for RhuDex®. We have a new, optimized formulation for this candidate and now want to prove the clinical relevance of RhuDex®'s mode of action as quickly as possible. The PBC indication offers an extremely useful and rapid way to achieve this goal. The results will be highly valuable for the further development of RhuDex® in the treatment of rheumatoid arthritis."
The objective of the clinical formulation trial was to develop an optimized oral formulation of the active substance suitable for the treatment of chronic diseases. All endpoints of the study were met. The new formulation is characterized by an optimized pharmacokinetic profile, excellent tolerability and a reduction of dose units. Based on the results of this study, RhuDex® will now be administered in a formulation based on Gelucire. This excipient is a known lipid-based compound belonging to the group of excipients "generally regarded as safe" (GRAS), and is used in marketed drug formulations.
With the new formulation, Medigene plans to initiate a phase II clinical proof-of-concept study with RhuDex® for the treatment of autoimmune diseases. Medigene will conduct this study in the indication of primary biliary cirrhosis (PBC), allowing the company to generate widely accepted clinical data on relevant disease parameter modification after only three months of treatment. In addition, patients with PBC do not receive explicit immunomodulating baseline therapy, as is the case, for example, in the treatment of rheumatoid arthritis. Thus, this patient group is suitable to preliminarily confirm that RhuDex®, due to its specific mode of action, does not adversely affect the ability to mount a spontaneous inflammatory reaction. Therefore, this clinical study is an important step for the further development of RhuDex® in the treatment of rheumatoid arthritis.
In parallel to the planned initiation of this proof-of-concept study, Medigene has initiated additional regulatory non-clinical studies to enable the necessary chronic treatment of patients with autoimmune diseases. Also, non-clinical studies are being conducted to integrate additional translational aspects into clinical development.
About RhuDex®: Medigene is developing RhuDex® as an oral, disease-modifying drug for the treatment of autoimmune diseases such as rheumatoid arthritis. RhuDex® is a CD80 antagonist that blocks undesired T-cell activation and thus has an immunomodulating and anti-inflammatory effect. Therefore, this drug candidate can be classified with the group of "Disease-Modifying Antirheumatic Drugs" (DMARDs). In a phase IIa trial in 29 patients in the indication rheumatoid arthritis, RhuDex® showed initial signs of biological activity.
About RhuDex® RapidFACT(TM) formulation study: During the recently completed clinical formulation study, variations of a RhuDex® formulation were given subsequently in single dose applications to ten healthy volunteers. Due to the innovative RapidFACT(TM) (Rapid Formulation Development and Clinical Testing) study design, variants of formulations could be tested and evaluated for their tolerability and pharmacokinetic profile over a short period of time, since the respective formulation variant was produced immediately prior to dosing.
All formulations investigated showed an excellent tolerability profile. The final formulation demonstrates the most advantageous prolongation of plasma absorption and elimination phases to achieve steady compound plasma levels with repeat daily dosing. Due to the highly flexible study design, additional preliminary data on the effect of concomitant food intake ("food effect") and on dose proportionality have also been obtained.
About Primary Biliary Cirrhosis (PBC): The autoimmune disease PBC is a chronic liver disease that initially affects the bile ducts. The bile ducts are progressively destroyed by inflammatory processes, causing biliary stasis and build-up of bile in the liver. Liver tissue is destroyed and replaced by connective tissue, liver cirrhosis develops. As in rheumatoid arthritis, the activation of T cells via a CD28-CD80 interaction has been described as involved in the pathogenesis of PBC, a process that is to be inhibited by RhuDex® treatment.
About Rheumatoid Arthritis: Rheumatoid arthritis is the most common inflammatory arthropathy worldwide. More than 0.5 - 1% of the world's population is affected by this chronic disease, which leads to pain, deformity, restricted mobility, and often stiffening of the joints. The body's own connective tissue (e.g., articular cartilage) is attacked and damaged by the individual's immune system. For this reason, rheumatoid arthritis is considered to be an autoimmune disease.
Medigene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology company headquartered in Martinsried/Munich, Germany. Medigene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene is the first German biotech company to have revenues from marketed products, which are distributed by partner companies. It has two drug candidates in clinical trials and is developing an innovative vaccine technology. For more information, please visit www.medigene.com.
This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® and RhuDex® are registered trademarks of Medigene AG. These trademarks may be owned or licensed in select locations only.
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Julia Hofmann & Kerstin Langlotz
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