Date: 2015-01-22
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: ImmuPharma (UK)
Product: Lupuzor™ (rigerimod)
Action
mechanism: peptide/immunomodulator agent. Lupuzor™ (Rigerimod, IPP-201101 and P140) has a novel mechanism of action aimed at modulating the body\'s immune system so that it does not attack healthy cells, without causing adverse side effects. It has been granted Fast Track status by the US FDA and approved to start Phase III under Special Protocol Assessment (SPA). This SPA was subsequently amended due to its strong safety and efficacy profile to allow for a reduced number of patients in the pivotal Phase III trial thereby reducing the projected cost of development considerably.
Disease: systemic lupus erythematosus
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: * On January 22, 2015, ImmuPharma and Simbec-Orion Group announced that they have entered into a Collaboration Agreement for the execution of ImmuPharma’s Pivotal Phase III clinical study of Lupuzor™ for the treatment of systemic lupus erythematosus. Lupuzor™ has been approved to start Phase III trials under a Special Protocol Assessment (SPA) due to its strong safety and efficacy profile. The multi-centre study will commence immediately and will recruit patients across Europe, the United States and other regions. The clinical study is titled “A 52-Week, Randomized, Double-Blind, Parallel-Group, PlaceboControlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus”. It is a pivotal study designed to demonstrate 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 EMA.
