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ImmuPharma announces positive data from IPP-201101 for lupus trial
By Elaine Rigoli
Tampa, Fla., May 10 - ImmuPharma, plc has successfully completed the placebo-controlled phase 1 study involving 24 healthy volunteers of its lead compound IPP-201101 for lupus, a chronic, life-threatening autoimmune disease.
The company said it has scheduled a meeting with the Food and Drug Administration to design the appropriate development program for market authorization.
This study, which took place in France, was the first administration in humans for IPP-201101 and was designed to assess its safety and tolerability, the company said in a news release.
These results have allowed ImmuPharma to proceed with a phase 2 proof-of-concept and efficacy study in lupus patients in Europe.
The dosing of lupus patients in this study is expected to start soon and the trial will measure recognized surrogate markers of clinical efficacy, in preparation of the pivotal phase 3 studies, the release said.
ImmuPharma is a drug-discovery and development company headquartered in London.
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