An Eli Lilly drug first approved to treat psoriasis is delivering encouraging data from a late-stage study testing it as a potential new treatment for a form of arthritis affecting the spine.
Indianapolis-based Lilly (NYSE: LLY) is trying to expand use of its drug ixekizumab (Taltz) to treat ankylosing spondylitis (AS), a condition that causes inflammation and pain in the vertebrae and pelvic joints. In advanced cases, the inflammation leads to the formation of new bone that causes sections of the spine to fuse in a fixed position. AS has no cure, though drugs are used to treat its symptoms.
Lilly said the preliminary results from its Phase 3 clinical trial show that its drug hit main and secondary goals, posting statistically significant improvements in the symptoms of AS. The 16-week, placebo-controlled study enrolled more than 300 patients diagnosed with AS whose condition had never been treated with a biologic drug. Patients in the treatment group received the injectable drug subcutaneously either once every two weeks or once every four weeks. The treatment group was compared to one group given a placebo and another given AbbVie’s (NYSE: ABBV) adalimumab (Humira). Lilly will follow the patients in its study for a year to evaluate the long-term effects of its drug.
Ixekizumab is an antibody drug that binds to a protein that causes inflammation called interleukin-17a. The FDA approved the drug in 2016 as a treatment for moderate-to-severe plaque psoriasis. Late last year, the FDA expanded the drug’s approval to psoriatic arthritis. The drug’s first approval came with additional guidance to patients that because the drug affects the immune system, it increases the risk of infection, and could also spark the development of an allergic or autoimmune condition. Lilly said side effects observed in the AS study were similar to those seen in the psoriasis studies, which included upper respiratory infections, reactions at the injection site, and fungal infections.
Though AS has no cure, there are other biologic drugs now available to treat the condition. Adalimumab is one of five FDA-approved tumor necrosis factor (TNF) drugs that block a protein that causes inflammation, according to the Mayo Clinic. Novartis’ (NYSE: NVS) secukinumab (Cosenytx), an interleukin-17 inhibitor, received the FDA’s nod as an AS treatment in 2016. The Novartis drug, which is also approved to treat plaque psoriasis, psoriatic arthritis, and scalp psoriasis, topped $1.1 billion in sales in 2016.
Lilly said that it plans to submit detailed data from its clinical trial later this year at unspecified scientific meetings and in peer-reviewed journals.