ImmuPharma PLC announced that Phase 3 clinical studies evaluating the safety and efficacy of Lupuzor — its lead compound to treat lupus – are now getting underway and enrolling patients in Europe, and continuing to enroll people in the U.S., where first dosing has already begun.
The pivotal trial, titled “A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 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 (LUPUZOR),” has a total of 45 investigator sites — 10 in the U.S. and 35 in Europe, including Czech Republic, France, Germany, Hungary, Italy, Poland, and the United Kingdom.
“Following the initial US sites being opened and the first Lupus patients having commenced dosing we are delighted that we have hit another key milestone with patient recruitment started in our first European site in France,” Tim McCarthy, Immupharma’s chairman, said in a press release. “We look forward to providing further positive updates on this Lupuzor Phase III study as it progresses throughout this year and 2017.”
Lupuzor (rigerimod) is a synthetic peptide that modulates the immune system of systemic lupus erythematosus patients by modifying the behavior of some of the key cells involved in the pathogenesis of the disease. Trial participants will be randomly assigned to receive Lupuzor 200 mcg subcutaneously, or placebo, every four weeks for a total of 48 weeks, plus standard care. The trial expects to conclude in December 2017, and to enroll about 200 people.
More information on the trial is available through its clinical trials.gov site.
Corbus Pharmaceuticals Holdings, Inc., announced it will soon begin a Phase 2 clinical trial to test the efficacy, safety, tolerability, and biologic effects of its drug candidate, Resunab, in patients with systemic lupus erythematosus (SLE).
Resunab is a first-in-class, synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Resunab has the potential to be a safe and potent anti-inflammatory drug with a unique mechanism of action to treat a range of chronic inflammatory diseases.