Business
Positive Final Lupuzor Trial
Positive Final Lupuzor Trial.
About this update from Immupharma Plc
[{"type":"text","content":"\n RNS Number : 7400C Immupharma PLC 19 November 2009 \n \nConference Call\nImmuPharma will host a conference call for analysts and investors to discuss this announcement at 15:45 GMT / 10:45 EST / 07:45 PST today. The dial-in details are: +44 (0)20 8609 1435 or US toll free: 1 866 793 4279, participant PIN code 311368#. \n\n\n\n\n\nFOR IMMEDIATE RELEASE\n\n\n19 NOVEMBER 2009\n\n\n\n\n\nImmuPharma PLC\n(\"ImmuPharma\")\n\nEncouraging FINAL PHASE IIb RESULTS seen with LUPUZOR™ \nIN SYSTEMIC LUPUS ERYTHEMATOSUS\n\n~ Greatest benefits seen in patients with moderate to severe \nSystemic Lupus Erythematosus ~\n\nImmuPharma PLC (LSE: IMM) the specialist discovery and development pharmaceutical company is pleased to announce today the final results from a Phase IIb trial of LUPUZOR™ in active patients with Systemic Lupus Erythematosus (SLE). Lupuzor™ administered at 200 mcg once-a-month for 3 months plus standard of care achieved a clinically significant improvement in patient response rate as measured by the combined score compared to placebo plus standard of care. The study results also show that Lupuzor™ was generally well tolerated, with adverse event rates lower with Lupuzor™ when compared to placebo.\n\nHighlights\n\n\nLupuzor™ achieved a clinically significant improvement in patient response rate versus placebo in the intention to treat (ITT) analysis\n\n\nThe improvement was statistically significant in a subgroup (90% of the ITT population) of moderate to severe patients\n\n\n62% of this sub-group of patients were responders according to both a composite clinical score and a decrease of 4 points of the SLEDAI score when treated with Lupuzor™ 200 µg every 4 weeks for 12 weeks compared to 41% on placebo\n\n\nLupuzor™ was generally well tolerated with fewer serious AEs leading to discontinuation\n\n\n\nDetails of the Phase IIb study with Lupuzor™ \n\nThis phase IIb study was a randomized, double-blind placebo controlled, dose-ranging study in 150 (initially planned 204) patients designed to evaluate the efficacy of Lupuzor™ in a three-month treatment period of either sub...