The first patients have been dosed in a Phase III clinical trial testing AstraZeneca’s treatment for lupus nephritis (LN).
The IRIS Phase III trial will be conducted in multiple countries across two years and is expected to enrol up to 360 participants aged between 18 and 70. The trial will assess the efficacy and safety of AstraZeneca’s monocloncal antibody Saphnelo when treating patients diagnosed with active Class III or IV LN. In particular it will be assessed when added to a standard therapy consisting of mycophenolate mofetil and glucocorticoids.
Saphnelo is a treatment for moderate to severe Systemic lupus erythematosus (SLE) which has been approved in the US, Japan, Europe and Canada. IRIS is the first Phase III of Saphnelo to assess its potential in an indication other than SLE.
It’s estimated that up to 60% of patients with lupus develop kidney complications and in more severe cases, this can develop into LN1. LN is one of the common severe organ manifestations in SLE – a chronic autoimmune disease in which the immune system attacks healthy tissue in the body.
Eduardo Mysler, Medical Director and Rheumatologist at the Organización Médica de Investigación, Buenos Aires, Argentina, and the international coordinating investigator in the Saphnelo clinical development programme for LN, said: “The Phase II results of anifrolumab in lupus nephritis provided important evidence suggesting that blocking type I interferons is a potentially promising strategy for the treatment of lupus nephritis. I look forward to contributing to the next phase of anifrolumab’s development in this severe and often debilitating complication of lupus where new therapeutic options are needed.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added: “Lupus nephritis continues to represent a significant burden to patients worldwide. Following the approval of Saphnelo as the first new treatment for systemic lupus erythematosus in over a decade, the start of our IRIS Phase III trial in lupus nephritis is another important step forward in our ambition to bring Saphnelo to more patients with diseases where type I interferon is a central driver.”
- Lupus Foundation of America. The Expert Series: Kidney health and lupus. Available at: https://www.lupus.org/resources/the-expert-series-kidney-health-and-lupus. [Last accessed: May 2022]