Swedish Orphan Biovitrum has announced that it has decided to initiate two clinical programs with Kineret (anakinra) in North America, with the aim of evaluating two new potential indications for Kineret where a significant need for alternative treatment options exists: acute gout and Still’s disease.
An increasing body of evidence suggests the potential involvement of interleukin-1 (IL-1) in a number of autoinflammatory diseases, including rare systemic inflammatory diseases such as Still’s disease (systemic juvenile idiopathic arthritis and adult onset Still’s disease), as well as more common autoinflammatory diseases such as acute gout.
“We look forward to initiating clinical trials to evaluate potential indications where patients need additional treatment options,” says Kristina Timdahl, Medical Head Therapeutic Area Inflammation at Sobi. “We believe that there is a continued great potential for Kineret and are pleased to be able to further expand our strategic life-cycle development activities for the product in an effort to meet needs of the medical and patient communities.”
The acute gout program will include a dose-finding phase 2 study, followed by a planned phase 3 study designed to evaluate the efficacy and safety of Kineret treatment in resolving the auto-inflammatory driven pain of acute flares. The Still’s disease study is a phase 3 study designed to evaluate the efficacy and safety of Kineret in newly diagnosed adult and paediatric patients. The two clinical trials are expected to be initiated at the beginning of 2017 and take place primarily in North America. Both programs were reviewed in meetings with the US Food and Drug Administration (FDA) during 2015.
In addition, Sobi has been granted a US patent for a citrate-free formulation of anakinra which will expire in 2032. A corresponding patent has recently been allowed in Europe and may be granted in 2016. Sobi plans to work with the FDA and the European Medicines Agency (EMA) to define a pathway to integrate the new formulation to its manufacturing of Kineret in the future.