Taltz met the primary and all key secondary endpoints in the late-stage trial, called COAST-X. The 52-week trial evaluated the safety and efficacy of the psoriatic arthritis drug in nr-axSpA patients, who are considered to be treatment naïve to biologic disease-modifying anti-rheumatic drug (bDMARD).
Taltz met the primary endpoint at week 16 and week 52, by achieving a statistically significant improvement in the signs and symptoms of nr-axSpA. This was determined by the number of patients who registered Assessment of Spondyloarthritis International Society 40 (ASAS40) response, in comparison to placebo.
The monoclonal antibody also met the key secondary endpoints of the COAST-X trial at week 16 and week 52, which includes significant improvements in Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity (BASDAI).
Also, other major secondary endpoints were met, including the proportion of patients, who showed low disease activity and significant improvement in sacroiliac joint inflammation (SIJ) as evaluated by MRI, at week 16, among others.
In the trial, the safety profile of the drug was on par with its previously reported phase 3 studies with no new safety signals observed.
Oregon Health & Science University medicine professor and COAST program clinical investigator Atul Deodhar said: “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.
“The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population.”
Lilly said that based on the data of the COAST-X trial, it will submit to regulatory authorities this year seeking the approval of its monoclonal antibody for the treatment of nr-axSpA.
Currently, the drug is being reviewed by the US Food and Drug Administration (FDA) for the treatment of radiographic axSpA with regulatory action expected to be taken later this year.
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 U.S. for people with non-radiographic axSpA.
“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.”
In March 2016, the monoclonal antibody was approved by the FDA for the treatment of moderate-to-severe plaque psoriasis in adults.