RE: German article25 Apr 2018 00:29
Translated from the German report ......
New lupus drug: not immunosuppressive, fewer side effects - 23. April 2018 . Drucken - PHASE III STUDIE
LupuzorTM is the first non-immunosuppressive drug for lupus. Now there are promising data from the phase III clinical trial. A marketing approval is considered likely this year.
New treatment for lupus: LupuzorTM is about to be launched
Lupus patients can hope for a new drug: The Phase III clinical trial for LupuzorTM has just been successfully completed. This is the last phase before market approval. Also known as Rigerimod, IPP-201101 and P140, LupuzorTM has been used in conjunction with basic medicines in nearly 70 percent of patients. With nearly 60 percent of patients treated with placebo and basic drugs responding positively, LupuzorTM did not prove superior, but it was equally effective.
Consider the side effects
However, the new drug was superior in terms of safety: the study did not show any serious side effects as observed with standard drugs. In addition, LupuzorTM showed a response rate of 61.5 percent in patients who had anti-dsDNA autoantibodies, compared to 47.3 percent of patients receiving only placebo.
Lupus is an incurable autoimmune disease in which the body's immune system attacks healthy tissue. Previous therapies suppress the immune system or inhibit overstimulated B cells. In contrast, the new drug LupuzorTM suppresses only CD4T cells before they can overstimulate the lupus-causing B cells. Thus, lupus is stopped while healthy defense mechanisms remain intact. Scientists are talking about an immune modulator.
Market launch planned for 2018
The Phase III clinical trial began in late December 2015 with one patient in the US and later expanded to Europe. A total of 202 patients were included, divided into two groups: the first group received LupuzorTM and the second group a placebo. All patients also took other medications such as steroids, antimalarials, methotrexates, etc.
LupuzorTM was developed by the team of researchers led by Sylviane Muller from the Laboratory of Immunopathology and Therapeutic Chemistry of the French Center for Scientific Research CNRS and has already been successfully tested by ImmuPharma France in Phase I and II clinical trials. Due to the positive Phase III study results, the manufacturer now wants to apply for approval quickly. The launch in the US and five EU countries is scheduled for 2018.