ImmuPharma announces highly positive preliminary Phase II results for its potential blockbuster treatment for Lupus
17th October: 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.'... |
