ImmuPharma Extends Phase 3 Study of Lupus Therapy to Mauritius at Country’s Request
In a recent update on its pivotal Phase 3 clinical trial evaluating Lupuzor (rigerimod) as a potential treatment for lupus, ImmuPharma announced that it was complying with a request to open a trial site in Mauritius so that patients there could participate in the study.
According to the company, the leading foundation for the disease in Mauritius, Lupus Alert, invited the drug’s maker, Professor Sylviane Muller, to visit the country in May and meet with lawmakers, health policymakers and rheumatologists. The meetings were followed by the request for the trial’s extension. Cap Research will be leading the trial in that country and be responsible for patient recruitment.
“We are delighted to have been requested by the Mauritian Government and the Country’s leading Lupus specialists to participate in our trial. Mauritius with its high proportion of Lupus sufferers clearly highlights how necessary an effective Lupus therapy such as Lupuzor is needed for such a debilitating disease,” Tim McCarthy, chairman of ImmuPharma, said in a press release. “We look forward to providing further positive updates on our Lupuzor Phase 3 study as it progresses further through this year and into 2017.”
ImmuPharma anticipates that nearly 30 lupus patients in Mauritius will soon be enrolled and integrated in the ongoing trial, which started with an enrollment target of 200 adults with an established diagnosis of systemic lupus erythematosus (SLE) in the U.S. and across Europe.
The study (NCT02504645) is a 52-week, double-blind and placebo-controlled evaluation of the safety and efficacy of Lupuzor, 200 mcg, plus standard of care. Its primary outcome is change from baseline in the SLE Responder Index (SRI), a composite measure of disease activity, at week 52 of treatment.
Mauritius, with a population of about 1.2 million, has an estimated 3,000 people affected by the disease.
Lupuzor, previously known as IPP-201101 or P140, is designed to modulate the body’s immune system so that it will not attack healthy cells, with no associated adverse side effects. Its benefits include the possibility to halt disease progression in a substantial proportion of patients.
ImmuPharma announced that the trial began dosing its first European patients in June.