Eli Lilly and Company announced results from its COAST-X Phase III clinical trial of Taltz (ixekizumab) in non-radiographic axial spondyloarthritis (nr-axSpA) in patients who had no previous disease-modifying anti-rheumatic drug (bDMARD) treatment.
The drug met the primary endpoint of the trial at both week 16 and week 52. It provided statistically significant improvement in the signs and symptoms of nr-axSpA based on proportion of patients who hit Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared to placebo.
It also met the secondary endpoints at the same time markers, including improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), significant improvement in Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of patients achieving low disease activity, significant improvement in sacroiliac joint inflammation as assessed by MRI, and significant improvement in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score.
Axial spondyloarthritis is a chronic inflammatory disease that mostly affects the sacroiliac joints and the axial skeleton. It is believed to affect about 4.5 million adults globally. It is defined as a single disease entity, with a subset of patients defined by the presence of a radiographically defined structural damage of the sacroiliac joints and another without clear structural damage radiographically. The two subgroups have similar disease burden and clinical features, including spinal inflammation and chronic inflammatory back pain.
Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine. As a result, it inhibits interaction with the IL-17 receptor. IL-17A is involved in normal inflammatory and immune responses. Taltz prevents the release of pro-inflammatory cytokines and chemokines.
“Non-radiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients,” stated Atul Deodhar, professor of medicine, Oregon Health & Science University and clinical investigator for the COAST program. “The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population.”
Lilly expects to submit the Taltz results to regulators this year for approval for nr-axSpA. Its application for axSpA is currently under review with the U.S. Food and Drug Administration (FDA) with a target action date later this year.
The drug is currently approved for adults with active psoriatic arthritis and adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It was approved for plaque psoriasis in March 2017 and for psoriatic arthritis in December 2017.
“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 U.S. for people with non-radiographic axSpA,” stated Christi Shaw, president, Lilly Bio-Medicines. “The COAST-X data add to the growing body of evidence from our COAST program, which demonstrates that Taltz may work across the axSpA disease spectrum.”
Despite the approval, Lilly shares were down slightly, 1.7%, to $113.26 in premarket trading this morning. The company also announced a global licensing and research collaboration with Avidity Biosciences focused on developing new immunology drugs. Under that deal, Lilly will pay Avidity $20 million upfront and an investment of $15 million. Avidity will be eligible for up to $405 million in various milestone payments, as well as tiered royalties ranging from the mid-single to low-double digits on any product sales that come out of the collaboration.