Immupharma PLC
17 October 2006
For Immediate Release 17 October 2006
ImmuPharma announces highly positive preliminary Phase II results for its
potential blockbuster treatment for Lupus
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,
announced today that its potential blockbuster IPP-201101 for Lupus treatment
has met its Phase II primary endpoints.
IPP-201101 is a drug that specifically modulates the immune system of Lupus
patients by modifying the behaviour of some of the key cells (CD4+ T cells)
involved in the pathogenesis of the disease. Lupus patients are often associated
with high levels of antibodies against their own DNA (anti-dsDNA antibodies).
The use of these antibodies as 'surrogate markers', e.g. indicators of the
overall modulation of the immune system of Lupus patients are particularly
useful with our drug due to its mechanism of action.
Phase II clinical trial highlights
• Study was a proof of concept, dose ranging and safety study
• The drug met its primary endpoints (p< 0.0001)
• The anti dsDNA antibodies decreased dose dependently and reductions of
47% were achieved
• In one of the two dose groups, 80% of the patients were responders
• The profile of other biomarkers supported the validation of the Proof of
Concept
• Excellent safety and tolerability profile
• An US IND is expected to be filed in Q1 2007 for the Phase II/III program
This study in Lupus patients was a proof of concept, dose ranging, safety,
multi-centre European study. The proof of concept was assessed by measuring the
decrease of anti dsDNA antibodies as a surrogate marker for efficacy and IL10, a
cytokine, to ascertain its mechanism of action. The drug was administered 3
times by subcutaneous injections 2 weeks apart at doses of 200(micro)g and 1000
(micro)g and the patients were monitored one month after treatment stop.
Clinical parameters were also assessed but have not been fully evaluated yet.
Dr Robert Zimmer, President & Chief Scientific Officer said: 'We are very
pleased by these results. They are in line with our preclinical results and
confirm our view on the global mechanism of action of IPP-201101. Importantly it
paves the way for the Phase II/III study in Europe and the US as discussed with
the FDA'.
Dimitri Dimitriou, CEO added: 'It is very exciting to deliver ahead of time
positive results, especially as we have been in discussions with a number of big
pharma companies on potential deals.'
For further information please contact:
ImmuPharma PLC:
Dimitri Dimitriou, Chief Executive Officer tel: +44 20 7152 4080
Richard Warr, Chairman tel: +44 20 7152 4080
Dr Robert Zimmer, President & Chief Scientific Officer tel: + 33 389 32 76 50
Buchanan Communications:
Lisa Baderoon tel: + 44 20 7466 5000
Rebecca Skye Dietrich tel: + 44 20 7466 5000
Dawnay Day Corporate Finance:
Gerald Raingold tel: + 44 207 509 4570
David Floyd tel:+ 44 207 509 4570
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:
o blockbuster potential in niche markets
o low promotional costs in few specialised physicians and centres and
o 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
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