Medigene Achieves Positive Formulation Study Results for Rhudex and Announces Phase II Proof-of-Concept Study for the Treatment of Autoimmune Diseases
• 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.
- End -
Contact Medigene
Julia Hofmann & Kerstin Langlotz
Tel.: +49 - 89 - 20 00 33 - 33 01
Fax: +49 - 89 - 20 00 33 - 29 20
Email: investor@medigene.com
Posted: June 2012
