Products and clinical projects

Drugs on the market:
Eligard ®
Veregen ®

Projects in clinical development:
EndoTAG TM-1
RhuDex ®

Technologies:
EndoTAG TM
AAVLP

Strategic Investments
Immunocore Ltd.
Catherex, Inc.

RhuDex®

Autoimmune diseases

Orally available therapy for rheumatoid arthritis
RhuDex® targets one of the most common diseases: rheumatoid arthritis. T-cell activation is pivotal in the onset of rheumatoid arthritis. It is triggered by interaction between specific proteins on immune cell surfaces. The CD80 protein plays a key role in this process. Its interaction with the CD28 protein, a receptor on the surface of T cells, is an essential step in T-cell activation. RhuDex® can bind to CD80, preventing the interaction with CD28, and thereby interrupt an important signaling pathway. Since RhuDex® is the first orally available drug candidate of this type, it would be excellently positioned to compete in this billion-euro market.

Following the successful completion of a clinical phase IIa trial with 29 patients, a clinical phase I trial of RhuDex® in a newly developed formulation as a tablet was conducted in the first half of 2008. This trial was put on hold in July 2008, after a trial participant had died of myocardial infarction. The autopsy revealed severe impairment of cardiac function of the volunteer. For safety reasons, however, the company proceeded to test RhuDex™ in a series of further laboratory studies in coordination with the MHRA. These tests did not indicate any negative effects of RhuDex® on the vascular system.

 
Outlook
In 2010 MediGene is going to conduct further preclinical studies with RhuDex®, in order to specify the therapeutic window, thus optimizing the clinical development program. Clinical development is expected to be resumed either in the fourth quarter of 2010 or in the first quarter of 2011. Within the scope of its strategic focusing MediGene intends to out-license this immunological drug candidate once clinical proof of concept has been achieved, if not earlier.


RhuDex® acting as an anti-inflammatory agent


T-cell activation by certain immune cells in the diseased joint is a key step in the onset rheumatoid arthritis.

1)   T-cell activation requires interaction between the surface proteins CD80 and CD28

2)
  RhuDex® prevents the interaction between CD80 and CD28, thus acting as an anti-inflammatory agent
 
   

Rhudex® is a trademark of MediGene Ltd.