The phase IIb clinical study is designed to evaluate the efficacy and safety of IPP-201101 in patients with Systemic Lupus Erythematosus (SLE). The primary objective of the study is to assess the effect of subcutaneous IPP-201101 on the signs and symptoms of disease activity in subjects with active SLE, over a 12-week treatment period, compared to placebo.
The phase IIb study has been designed as a multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate the safety, tolerability and efficacy of two doses of subcutaneous IPP-201101 plus standard of care, versus placebo plus standard of care in Subjects with SLE. The first patients have been dosed in Buenos Aires, Argentina. The study is being conducted in 7 countries in 43 sites, across Europe and Latin America, and is expected to enrol up to 204 patients.
Dr Robert Zimmer, MD, PhD, President and Chief Scientific Officer of ImmuPharma said: “We are delighted to announce further progress in IPP-2011101 development while we believe more than ever that IPP-201101 will significantly improve treatment options and the quality of life for SLE patients. IPP-201101 represents a novel strategy for the treatment of SLE that has demonstrated encouraging potential in initial clinical studies. We are optimistic that the study will proceed well in the coming months and we look forward to reporting on our progress later this year.”
For further information please contact:
ImmuPharma PLC: Dimitri Dimitriou, Chief Executive Officer +44 20 7152 4080 Dr Robert Zimmer, President & Chief Scientific Officer + 33 389 32 76 50 Richard Warr, Chairman +44 20 7152 4080
Buchanan Communications + 44 20 7466 5000 Lisa Baderoon Rebecca Skye Dietrich
Panmure Gordon & Co Andrew Burnett +44 151 243 0963
For company information, visit www.immupharma.com
