Findings dealing with the therapy’s effectiveness are expected to be released by the end of April 2018. Lupuzor displayed a robust safety profile after being administered for a year, researchers said. A pivotal trial is one intended to provide the kind of evidence needed for a treatment’s regulatory approval.
The company plans a follow-up study that involves patients who completed the Phase 3 trial receiving Lupuzor plus a standard therapy for six months.
Patients and researchers asked for the follow-up study, ImmuPharma said. The results will be analyzed independently of those in the Phase 3 trial, it said.
“We are delighted to announce this major milestone for ImmuPharma in having completed on track this pivotal Phase 3 trial for Lupuzor,” Robert Zimmer, the president and chief scientific officer of ImmuPharma, said in a press release.
Lupuzor (rigerimod) has a unique way of regulating the immune system so it won’t attack healthy cells. It inhibits the activation of auto-reactive T-cells, which attack the body’s own tissue. Unlike other immune-modulating drugs, Lupuzor does not affect healthy immune cells. They remain active to fight infections.
The Phase 3 trial of Lupuzor (NCT02504645), launched in June 2016, involved 200 lupus patients at 30 centers around the world. Participants were randomly assigned to receive either 200 micrograms of Lupuzor under the skin, or a placebo, every four weeks. Lupuzor and the placebo were administered in combination with a standard therapy.
The study aimed to assess Lupuzor’s safety and effectiveness, when combined with a standard therapy, compared with standard treatment alone.
“I would like to take this opportunity of thanking all of our clinical investigators, Simbec-Orion, our clinical research organization, and the ImmuPharma France team led by Dr. Fanny Valleix, head of clinical research,” Zimmer said. “All were paramount in the execution and completion of this trial.
“With the continued robust safety achieved over this trial, we look forward with continued confidence to reporting top-line results of the study,” he added.