Lupus Drug Candidate Lupuzor Pivotal Phase 3 Clinical Trial Doses First European Patients
ImmuPharma, a specialized drug discovery and development pharmaceutical company, announced its Phase 3 clinical trial of Lupuzor (rigerimod), the company’s lead potential breakthrough lupus treatment candidate, has made progress and has begun dosing its first European patients.
In its update, ImmunoPharma said the Lupuzor Phase 3 study will enroll patients across 10 sites in the U.S. and 35 sites in Europe for a total of 45 research institutions involved.
“This is a further key milestone for ImmuPharma’s Lupuzor trial, with now both the U.S. and European sites dosing lupus patients. We look forward to providing further positive updates on this Lupuzor Phase 3 study as it progresses throughout this year and 2017,” said ImmuPharma Chairman Tim McCarthy in a press release.
Lupus is a chronic, potentially life-threatening autoimmune disease which attacks multiple organs such as the skin, joints, kidneys, blood cells, heart, or lungs. There is currently no known cure for this inflammatory disease, and 1.4 million people are estimated to suffer from it in the seven largest world markets (U.S., Japan, Germany, France, Spain, the U.K., and Italy) alone.
Lupuzor (rigerimod), previously known as IPP-201101 or P140, has a novel mechanism of action aimed at modulating the body’s immune system so it won’t attack healthy cells, with no associated adverse side effects. Its benefits include the possibility to halt disease progression in a substantial proportion of patients.
After completing successful Phase 1, 2a and 2b studies, it has now been given “gold standard” approval by the U.S. Food and Drug Administration (FDA) along with a Special Protocol Assessment (SPA) and Fast Track Designation to commence the pivotal Phase 3 trial.
Prof. Sylviane Muller, who invented Lupuzor, will be the key presenter of the unique mechanism of action of the drug at the company’s dedicated symposium, taking place June 8-9. Muller will provide additional evidence on the role of the P140 molecule in the potential treatment of other autoimmune diseases.
A video of the presentation will be available online on ImmunoPharma’s website beginning June 13.