Eli Lilly has reported positive results from the Phase III COAST-X clinical trial of Taltz (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA).
The trial met the primary endpoint of statistically significant improvement in the signs and symptoms of the disease compared to placebo, as well as key secondary endpoints, at weeks 16 and 52.
Secondary endpoints included significant improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity (BASDAI), sacroiliac joint inflammation (SIJ), and 36-Item Short Form Health Survey (SF-36) Physical Component Summary.
During the trial, the safety profile of the therapeutic was found to be consistent with that of prior Phase III studies. Investigators did not detect any new safety signals.
Axial spondyloarthritis is a chronic inflammatory disease that primarily affects the sacroiliac joints and the axial skeleton. nr-axSpA is characterised by no clear structural damage radiographically.
Taltz is a monoclonal antibody designed to selectively bind to and block interleukin 17A (IL-17A) cytokine interaction with the IL-17 receptor. The therapeutic is intended to prevent the pro-inflammatory cytokines and chemokines release.
The multi-centre, randomised, double-blind, placebo-controlled Phase III COAST-X trial assessed the safety and efficacy of the drug in biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve patients over 52 weeks.
Lilly Bio-Medicines president Christi Shaw said: “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 non-radiographic axSpA.
“The COAST-X data add to the growing body of evidence from our COAST programme, which demonstrates that Taltz may work across the axSpA disease spectrum.”
The COAST programme is evaluating ixekizumab across different population subsets of axSpA patients.
The programme also comprises COAST-V and COAST-W trials in bDMARD-naïve ankylosing spondylitis (AS)/radiographic axSpA patients and for treating AS/radiographic axSpA patients with an inadequate response or intolerance to TNF inhibitors, respectively.
Eli Lilly submitted a US regulatory application for radiographic axSpA and the US Food and Drug Administration (FDA) decision is expected later this year.