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Initiation of Phase IIb trial
Initiation of Phase IIb trial.
About this update from Immupharma Plc
[{"type":"text","content":"\n Immupharma PLC\n06 December 2007\n\n\nFor Immediate Release 6 December 2007\n\n\n\n\n ImmuPharma PLC\n\n\n Initiation of Phase IIb trials for IPP - 201101 in patients with Lupus;\n Allows earlier release of efficacy data in mid 2008\n\n\n\n\n\nImmuPharma PLC (LSE:IMM), ('ImmuPharma' or the 'Company'), the specialist drug\ndiscovery and development company, announces today that following its\ndiscussions with the US Food and Drug Administration ('FDA'), it has obtained\nfeedback that refines the phase II/III programme for IPP- 201101 in patients\nwith Systemic Lupus Erythematosus. The outcome of this consultation with the\nregulator has been the segmenting of the development programme into separate\nphase IIb and phase III trials. The company had previously expected a single\nphase II/III trial in 240 patients over 12 months. The revised plans allow the\ncompany to have additional phase II data, which has the potential to enhance its\ncommercial attractiveness, earlier than previously expected and continuing with\na simpler phase III trial in Q3 2008, broadly in line with previous development\ntimelines. ImmuPharma expects the first patients to be dosed into the phase IIb\ntrials very shortly.\n\n\nAs part of an Initial Investigational New Drug application, the company filed in\nJuly 2007 with the FDA a protocol for a phase II/III double blind, randomised,\nplacebo controlled, multicentre study in 240 patients to be treated for 12\nmonths. Following its meeting with the FDA, ImmuPharma is now planning to\nconduct a phase IIb study in 200 patients in Europe and Latin America. This\nphase IIb study, which has just started, is a robust, randomised,\nplacebo-controlled, three-arm dose ranging study in patients treated for three\nmonths with an additional three month follow-up. It is expected that the\npatients from this phase IIb trial will be rolled into a one-year 'open label'\nsafety and efficacy study which should report by Q3 2009. In addition, in Q3\n2008 a similar but pivotal phase III study will be commenced in an additional\n200 patients in the US, Europe and Latin America, to be treated for a period of\nsix months. The phase III study is expected to report by Q3 2009. In parallel\nwith the phase IIb trial, the company will also complete a long-term\npre-clinical toxicology study as part of regulatory requirements.\n\n\nD...