Date: 2015-01-22
Type of information: Clinical research agreement
Compound: Lupuzor™ (rigerimod)
Company: ImmuPharma (UK) Simbec-Orion (UK)
Therapeutic area: Autoimmune diseases
Type agreement: clinical research
Action mechanism: peptide/immunomodulator agent. Lupuzor™ (rigerimod or 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
Details: * 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™. The compound has been granted Fast Track status by the FDA and 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. Simbec-Orion has agreed that it will reinvest a significant proportion of its fees in new ordinary shares at a fixed price of 150p per share, representing a premium of 206% to the closing mid-market price on 21 January 2015. It is expected that over the duration of the study Simbec-Orion will subscribe for approximately 900,000 new ordinary shares. 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”.
Financial terms:
Latest news:
