Lupuzor TM, the most promising drug candidate yet for the treatment of lupus, enters phase III clinical trial.
Lupus is an autoimmune disease characterized by inflammation affecting various parts of the body including joints, skin, kidneys, heart, lungs, and the brain. There is currently no cure for lupus, however active disease ‘flares’ can be controlled by drugs such as corticosteroids or immunosuppressant drugs.
LupuzorTM is a small protein sequence that acts to inhibit the autoimmune response, thereby potentially correcting the inappropriate activation of the immune system against ‘self’. It was developed by the Centre National de la Recherche Scientifique, (CNRS) in France. Pre-clinical studies in mice demonstrated ability of Lupuzor to delay the development of lupus in mice. Lupuzor has passed through phase I and II clinical trials, that demonstrated the most promising results ever for treating lupus, with disease regression reported in 62% of patients.
Lupuzor is now set to be tested in a large Phase III clinical trial across Europe and the United States. Participants who are aged between 18 and 70 years of age with a diagnosis of Systemic Lupus Erythematosus will be eligible to take part in the study. Participants who are currently on other forms of therapy may not be eligible to take part. The study will assess the safety of Lupuzor, in addition to patients’ response to Lupuzor in terms of disease activity, pain, and quality of life, at various time points during the 52-week study. Completion of the trial is estimated for mid-2017, after which Lupuzor could be available as the first ever non-immunosuppressant drug for treating lupus.
News Release: “Treatment of lupus: LupuzorTM enters phase III” Available from: http://www.alphagalileo.org/ViewItem.aspx?ItemId=159376&CultureCode=en Last Accessed: December 16, 2015
clinicaltrials.gov “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)” Available from: https://www.clinicaltrials.gov/ct2/show/NCT02504645?term=lupuzor&rank=1 Last Accessed: December 16, 2015
Lupuzor Website: www.lupuzor.com Last Accessed: December 16, 2015
Written by Deborah Tallarigo, PhD