Immupharma PLC
30 October 2006
For Immediate Release 30 October 2006
ImmuPharma announces further data from its IPP- 201101 phase II Lupus trial
showing significant clinical improvement in patients
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,
announced today further data from its phase II trial with IPP-201101 for Lupus.
Patients who received IPP-201101 on only 3 occasions, 2 weeks apart,
demonstrated a significant clinical improvement in their condition in addition
to the decrease of their biomarkers.
ImmuPharma announced on 17 October 2006 that the phase II trial of IPP-201101
met its primary end-points. The study was designed to measure biomarkers,
including reduction in anti-dsDNA auto-antibodies and increase in IL-10. The
study was not expected to show significant clinical improvement, primarily due
to its short treatment duration. Many of the patients that were treated with
the drug showed reduction in their auto-antibodies and showed also significant
improvement in their condition.
Phase II clinical highlights:
• IPP-201101 significantly improved the clinical status of a number of the
patients treated.
• 50 % of the patients in one of the two dose groups showed a reduction of
at least 50 % of their SLEDAI score, a specific scale used to measure the
condition of Lupus patients.
• It appears that a correlation exists, with this drug, between the decrease
of the SLEDAI scores and the decrease of the surrogate markers (anti-dsDNA
auto-antibodies) which could reach statistical significance with a larger
number of patients.
• Establishing such a correlation was one of the key objectives of the Phase
II/III trial as discussed with the FDA earlier this year (see ImmuPharma
announcement of 2 October 2006).
IPP-201101 is a drug that specifically modulates the immune system of Lupus
patients by modifying the behaviour of some of the key cells involved in the
pathogenesis of the disease. The clinical profile of Lupus patients is generally
assessed by standardized scales such as SLEDAI (SLE Disease Activity Index): the
lower the score, the better the condition of the patient. During this Phase II
study, the SLEDAI scores were assessed on multiple occasions even though the
study was not designed or powered to demonstrate clinical benefit as primary
endpoint due to the short treatment period.
Dr. Robert Zimmer, President & Chief Scientific Officer said: 'We could not have
expected better results from this study with such a short period of treatment.
We are absolutely delighted that we were able to demonstrate these clinical
improvements in Lupus patients, paving the way for hopefully a very promising
and effective treatment for Lupus. This also gives us more confidence in the
outcome of the Phase II/III programme.'
For further information please contact:
ImmuPharma PLC:
Dimitri Dimitriou, Chief Executive Officer +44 20 7152 4080
Richard Warr, Chairman +44 20 7152 4080
Dr Robert Zimmer, President & Chief Scientific + 33 389 32 76 50
Officer
Buchanan Communications + 44 20 7466 5000
Lisa Baderoon
Rebecca Skye Dietrich
Notes to Editors:
About ImmuPharma
ImmuPharma PLC is a drug discovery and development company headquartered in
London, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has
research operations in France (ImmuPharma (France) SA) and Switzerland
(ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs,
largely based on peptide therapeutics, to treat serious medical conditions such
as autoimmune diseases characterised by:
• blockbuster potential in niche markets
• low promotional costs in few specialised physicians and centres and
• lower risk of drug development and lower development costs
ImmuPharma is a currently developing drug candidates for three different medical
conditions, each of which would represent a significant breakthrough in its
field. The furthest advanced drug candidate targets Lupus, a disease for which
there is currently no cure or specific treatment. The other two address moderate
to severe pain (such as that experienced by cancer sufferers and post-operative
patients), and MRSA and similar severe hospital-acquired resistant infections.
All three have significant sales potential as well as low marketing costs and a
relatively low risk of development failure. One or more have the potential to be
fast-tracked by the US Food and Drug Administration according to 'Guidance for
Industry: Fast Track Drug Development Programs - Designation, Development and
Application Review' issued July 2004 and could therefore obtain their market
authorization by 2010.
Key to the potential success of ImmuPharma is its unique collaborative agreement
with Centre National de la Recherche Scientifique, France's scientific research
institution. This agreement grants ImmuPharma worldwide exclusive rights to
exploit certain key discoveries.
In addition to its three leading drug candidates, ImmuPharma has a drug
development pipeline using its rights to a virtual chemical library of hundreds
of thousands of molecules as well as an innovative technology for converting
peptides to drug candidates.
ImmuPharma has the option to commercialise its assets itself or to license them
to other pharmaceutical companies at an earlier stage.
The products
Treatment of Lupus (IPP-201101)
This is a long-term treatment for Lupus, a chronic, life-threatening autoimmune
disease where the immune system attacks healthy cells. There is currently no
cure and existing medications only treat the symptoms whereas ImmuPharma's drug
candidate has the potential to produce remission of the disease in a substantial
proportion of patients.
Based on independent forecasts, the value of ImmuPharma's Lupus drug is
estimated to be 'substantial' with peak annual sales forecast to generate in
excess of $4 billion.
Severe pain relief (IPP-102199)
ImmuPharma is developing a non-addictive compound for relieving moderate to
severe pain, such as experienced by cancer sufferers and post-surgical patients.
Most existing treatments are opioid-based (explain) and tend to have serious
side effects. ImmuPharma's new treatment is based on met-enkephalin, the body's
internal analgesic. IPP-102199 is being developed to have major advantages over
morphine such as longer pain relief duration and reduced side effects. The
market for chronic opioids in the US currently exceeds $3.5 billion and is
growing by more than 10 to 20 per cent a year.
Antibiotic for MRSA and similar highly resistant infections (IPP-203101)
This is a novel antibiotic to counter the effects of MRSA and other severe
hospital-acquired, resistant infections which affect some two million people in
the US, according to the US Centers for Disease Control and Prevention.
ImmuPharma's drug candidate uniquely uses an electrical charge rather than
biochemical methods against MRSA and other bacterial strains. It is hoped this
novel approach will reduce their potential to become resistant.
This information is provided by RNS
The company news service from the London Stock Exchange DLFLQBBZFBQ
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