Orally available therapy for rheumatoid arthritis
RhuDex™ targets one of the most common diseases: rheumatoid arthritis.
RhuDex™ is designed to block the disease-causing mechanism at
a very early stage. 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, thereby interrupting an important signaling
pathway. This is intended to inhibit the inflammatory process, causing
the disease to subside. CD80 is a well-suited target for the treatment of
rheumatoid arthritis. This was already verified by an effective drug using
this approach. That drug is administered by protracted infusions, whereas
RhuDex™ is to be taken as a tablet. Since RhuDex™ is the first orally
available drug candidate of this type, it would be excellently positioned
to compete in this billion-euro market.
In June 2008, MediGene achieved all objectives in a phase IIa clinical
trial with a working formulation of RhuDex™. Apart from positive safety
data and its good adsorption after oral administration, the first indication
of RhuDex™‘s biological activity was observed. In addition, an easy-toadminister
tablet form of the active ingredient was developed in 2008.
In July 2008, MediGene put an ongoing phase I clinical study with the
new formulation of RhuDex™ as a tablet on hold. During the study, a
volunteer suffered an acute myocardial infarction and died. The autopsy
clearly proved that impairment of cardiac function had developed in the
patient over many years. In order to rule out any correlation between
this incidence and the study medication, MediGene initiated additional
preclinical testing in cooperation with the authorities. This should be
concluded in mid-2009.
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| RhuDexTM acting as an anti-inflammatory agent |
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T-cell activation by certain immune cells in the diseased joint is a key step in the onset rheumatoid arthritis.
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T-cell activation requires interaction between the surface proteins CD80 and CD28 |
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RhuDex®  prevents the interaction between CD80 and CD28, thus acting as an anti-inflammatory agent |
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RhuDexTM is a trademark of MediGene Ltd. |
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