Systemic lupus erythematosus (SLE or lupus) is a multisystem autoimmune disease that occurs when the immune system attacks the body’s cells and tissues leading to chronic inflammation, antibody production, and immune complex deposition resulting in tissue damage. Symptoms can be vague and vary from person to person, and consequently diagnosis can be difficult. More common in women than men, lupus can affect any part of the body.
Lupus increases a woman’s risk of other health problems and can also cause heart diseases, osteoporosis and kidney disease to occur earlier in life. There is no known cure for lupus, and the goals of treatment are to prevent flares, treat symptoms when they occur and reduce organ damage. Medication plays an important role in treating lupus, and therapies can involve NSAIDs, corticosteroids, antimalarial drugs or immunosuppressant/chemotherapeutic medication.
Lupus is currently the focus of intense research. Studies are currently looking at the genes that play a role in the disease and in the immune system, ways to change the immune system in people with lupus, lupus in different ethnic groups, environmental causes or triggers of lupus, the role of hormones and treatments for lupus.
Rationale: Preclinical studies in the MRL-(Fas)lpr murine model demonstrated that Cpn10 entirely prevented cutaneous lupus lesions as compared to vehicle-treated mice and suppressed lupus nephritis as evident from reduced serum creatinine levels, albuminuria and improved scores of disease activity and chronicity.
In 2012, independent analyses were conducted on the Cpn10 clinical and preclinical database (including the murine model demonstrating cutaneous lupus effects), intellectual property and hypothesised mechanism of action. Based on these findings, and on a clear regulatory pathway and commercial potential, systemic lupus erythematosus (“lupus”) has been identified as the most promising development target for Cpn10.
Following the acceptance by the FDA of its Investigational New Drug application (IND), Invion commenced its phase II clinical trial in lupus patients in July 2013.
The Protocol is entitled a “Double-blinded, randomized, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, and biochemical activity of intravenous Cpn10 administration in subjects with SLE.” The Protocol Number is IVXCpn001. The primary objective is to evaluate the safety, tolerability and efficacy of four-week treatment with Cpn10 in subjects with mild SLE. The adverse event profile and safety laboratory parameters will be monitored throughout the study. The primary outcome measure is the reduction from baseline serum IL-6 levels at the end of active dosing, comparing treatment to placebo cohort. Dose escalation is planned from 10mg IV twice weekly (the highest dose used to date) to greater than 100mg IV twice weekly as tolerated.
Further details of this clinical trial can be found at www.clinicaltrials.gov with the identifier: NCT01838694.