Regulatory submissions for Lilly’s Taltz in ankylosing spondylitis (AS) are on the cards for later this year after the drug hit primary and secondary targets in a late-stage trial.
The Phase III COAST-V trial assessed the safety and efficacy of Taltz (ixekizumab) in patients with the condition, which is also known as radiographic axial spondyloarthritis (axSpA), who had never received a biologic disease-modifying anti-rheumatic drug (bDMARD).
According to Lilly, the drug showed a statistically significant improvement in the signs and symptoms of AS, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks, when compared to placebo.
It was also noted that COAST-V is the first registration trial to use ASAS 40 as the primary endpoint, compared to the standard endpoint of ASAS20, in a move designed to lift treatment expectations.
“Many people with this chronic, debilitating disease are still searching for an effective treatment. These initial results suggest that Taltz, if approved for this indication, may have the potential to help people with this challenging disease,” said Dr Lotus Mallbris, vice president and immunology platform team leader, Lilly Bio-Medicines.
Full findings from the trial are to be disclosed at scientific meetings and in peer-reviewed journals later this year.
The company said it intends to submit Taltz for regulatory approvals pending additional data from the drug’s ongoing development programme later this year.
Taltz, an antibody that binds to interleukin-17A, a protein that causes inflammation and plays a role in the development of these conditions, was approved in Europe in January as a treatment for psoriatic arthritis.
