Eli Lilly's Taltz yields positive top-line results in Phase III non-radiographic axial spondyloarthritis trial

Eli Lilly on Monday announced that Taltz (ixekizumab) has met the primary and all major secondary endpoints in the late-stage COAST-X trial evaluating the IL-17A inhibitor for non-radiographic axial spondyloarthritis (nr-axSpA) in patients not previously treated with biologic disease-modifying anti-rheumatic drugs. The company said that based on the results, it plans to seek regulatory approval for Taltz this year in nr-axSpA, while a decision on its filing for the drug in radiographic axSpA, currently under review by the FDA, is expected later in 2019. 

"We're encouraged by the results of the COAST-X trial, which support our belief that Taltz could become the first IL-17A antagonist to be approved in the US for people with nr-axSpA," commented Christi Shaw, president of Lilly Bio-Medicines, adding that the findings "add to the growing body of evidence from our COAST programme, which demonstrates that Taltz may work across the axSpA disease spectrum." 

According to the company, Taltz met the primary endpoint of COAST-X at 16 weeks and at 52 weeks by significantly improving signs and symptoms of nr-axSpA, as measured by patients achieving Assessment of Spondyloarthritis International Society 40 (ASAS40) response, versus placebo. Taltz also met the major secondary objectives at both time points, including improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS) and in Bath Ankylosing Spondylitis Disease Activity (BASDAI), as well as the proportion of patients achieving low disease activity (ASDAS <2.1) and improvement in sacroiliac joint inflammation as assessed by magnetic resonance imaging at week 16. 

Eli Lilly said that Taltz's safety profile in COAST-X was "consistent" with previously reported late-stage studies, with no new safety signals detected. The company intends to submit detailed results from COAST-X at scientific meetings and in peer-reviewed journals later this year. 

Taltz was approved in the US in 2016 to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and was later expanded to include adults with active psoriatic arthritis. The FDA approved a label update for Taltz in 2018 to include data in psoriasis involving the genital area. 

Last month, the US regulator expanded the label for UCB's Cimzia (certolizumab pegol) injection to treat adults with nr-axSpA who have objective signs of inflammation. 

Separately on Monday, Eli Lilly also announced a global partnership with Avidity Biosciences "focused on the discovery, development and commercialisation of potential new medicines in immunology and other select indications." 

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