Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.ImmuPharma and Simbec-Orion have entered into a collaboration agreement to execute ImmuPharma's Phase III clinical trial of its lead compound Lupuzor to treat Lupus, a chronic, potentially life-threatening autoimmune disease.
Subscribe to our email newsletter
Lupuzor (also called as Rigerimod, IPP-201101 and P140) received fast track designation from the US Food and Drug Administration (FDA) as well as approval to start Phase III trials under a Special Protocol Assessment (SPA) due to its strong safety and efficacy profile.
ImmuPharma executive chairman Richard Warr said: "Lupuzor has been recognised as a significant asset by distinguished organisations. To enter phase III under the terms agreed for our partnership with Simbec-Orion demonstrates the commercial magnitude of our Lupuzor asset."
The multi-centre Phase III trial will begin immediately and will enroll patients across Europe, the US and other regions.
The 52-week, randomized, double-blind, parallel-group, placebo-controlled trial will evaluate the efficacy and safety of a 200mcg dose of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.
The trial is designed to show the safety and efficacy of IPP-201101 and as a last step prior to the filing of the drug for approval with the FDA and the European Medicines Agency (EMA).