Eli Lilly succeeds in phase three Taltz trial.
M2 PHARMA-April 25, 2019-Eli Lilly succeeds in phase three Taltz trial
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United States-based Eli Lilly and Company has succeeded in a phase three trial of its psoriatic arthritis drug Taltz (ixekizumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA), it was reported yesterday.
The product met the primary and all key secondary endpoints in the late-stage trial, called COAST-X.
The trial assessed the safety and efficacy of the psoriatic arthritis drug in nr-axSpA patients, who are considered to be treatment naive to biologic disease-modifying anti-rheumatic drug. It 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 demonstrated low disease activity and significant improvement in sacroiliac joint inflammation as evaluated by MRI, at week 16, among others. In the trial, the safety profile of the drug was on par with its earlier reported phase three studies with no new safety signals observed.
Based on the COAST-X trial data, Lilly will submit to regulatory authorities this year seeking the approval of its monoclonal antibody for the treatment of nr-axSpA.
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|Date:||Apr 25, 2019|
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