News

Company   Immupharma PLC
TIDM         IMM
Headline    Phase II Data
Released    07:00 17-Oct-06
Number     5314K

FOR IMMEDIATE RELEASE

London, 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                         +44 20 7152 4080
Richard Warr, Chairman                                                +44 20 7152 4080
Dr Robert Zimmer, President & Chief Scientific Officer      +33 389 32 76 50
 

Buchanan Communications

Lisa Baderoon                                                             + 44 20 7466 5000 Rebecca Skye-Dietrich

Dawnay Day Corporate Finance

Gerald Raingold                                                           + 44 207 509 4570
David Floyd                                                                 + 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:

  • 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)

Lupus is 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. By selectively modulating the aberrant T-cells in Lupus, 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 compound for relieving moderate to severe pain, such as experienced by cancer sufferers and post-surgical patients. Most existing treatments are derived from the opiate morphine and have serious side effects associated with a morphine-like mechanism of action. ImmuPharma’s new approach is based on met-enkephalin, one of the body’s internal analgesics. 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 is targeted at disrupting the membrane potential of MRSA and other bacterial strains. It is hoped this novel approach will reduce their potential to become resistant.

END