A novel new drug, based on the commonly used prednisone, has been recommended for European regulatory approval for treatment of morning stiffness resulting from rheumatoid arthritis (RA). The drug, sold under the name Lodotra™ is manufactured by the Swiss based Nitec Pharma AG.
RA stiffness and pain is caused by pro-inflammatory cytokines, such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-a), which peak during the night. Cytokines are molecules, such as hormones, that allow for communication between cells. Lodotra™ is a low dose prednisone tablet that interferes with the ability of IL-6 to cause inflammation.
Prednisone is a glucocorticoid, a class of drugs that are used to suppress inflammatory, autoimmune and allergic disorders by inhibiting the production of pro-inflammatory cytokines.
The novel part of the drug is that is in a class known as circadian cytokine modulator (CCM) which is taken at bedtime. The prednisone is released approximately 4 hours later and suppresses the night time pro-inflammatory cytokines. This results in reduction in early morning RA stiffness and pain.
Phase III studies on Lodotra™ were conducted on 288 patients in 26 European centers. The primary goal of the studies was the measure the improvement in morning stiffness. The results were published in the British medical journal The Lancet.
Nitec will next be seeking approval from the U.S. Food and Drug Administration and is conducting another round of Phase II trials in support of that. Since prednisone is also used for treatment of other conditions, such as asthma and polymyalgia rheumatica, Nitec will conduct further studies aimed at approval of Lodotra™ for those conditions.