July 8 2013 | By Márcio Barra
Novartis announced today that their experimental psoriasis drug secukinumab was more effective in a Phase III trial than Pfizer’s and Amgen’s Enbrel (Etarnacept) in clearing the skin of patients with moderate to severe plaque-type psoriasis.
The trial, called FIXTURE, is a pivotal trial intended for registration, where secukinumab was compared to both placebo and Enbrel. While final results will only be released later this year, secukinumab met all primary and secondary endpoints on the drug’s safety, tolerability and short term and long term efficacy parameters. Whether the findings will give secukinumab sufficient differentiation over the anti-TNF drugs – its ability to reduce the risk of severe infections compared with the anti-TNFs will be crucial – will become clearer when the data is released, possibly at the American College of Rheumatology in October
This are great news for Novartis, which told investors two years ago that secukinumab was a blockbuster contender for the anti-TNF-a biologics ruled psoriasis market, with its first regulatory filing slated for 2013.
Plaque psoriasis is believed to be caused by an inflammatory response initiated by the body’s immune system,where the immune system mistakes a normal skin cell for a pathogen, causing over production of new cell skins. It affects about 125 million people in the world, and there is currently no cure available, with the disease having a significant impact on the patient’s quality of life. Those suffering from the disease are also at a greater risk of developing diabetes and heart disease.
Novartis is among the group of companies developing new treatments for psoriasis, including Eli Lilly, AstraZeneca, Celgene and Amgen. It’s drug secukinumab is a fully human monoclonal antibody, and the first medicine that selectively binds to and neutralizes IL-17A, a key pro-inflammatory cytokine in the development of psoriasis, found in high concentration in skin affected by the disease. Brodalumab is another anti-IL17 therapy that Amgen recently partnered with AstraZeneca, currently going thorugh Phase III trials .
As for Enbrel (etarnacept), it is a TNF-a inhibitor and the current standard-of-care biologic therapy for plaque psoriasis (other biologics like Amevive from Biogen Idec and Raptiva from Serono and Genentech/Xoma are also approved in the US and other countries for the treatment of plaque psoriasis, all of them TNF-a inhibitors). Etarnacept binds to soluble TNF-a, thus preventing its interaction with TNF-a cell surface receptors. This inhibits the effects of TNF-a in the skin, such as the release of proinflammatory cytokines by keratinocytes and lymphocytes, as well as the increase in expression of adhesion molecules on endothelial cells.