Eli Lilly said on Tuesday that its Ankylosing Spondylitis treatment candidate, Taltz met the primary and all key secondary endpoints in COAST-V, a Phase 3 study.
The study has included a placebo arm and an active control arm (adalimumab) for comparison with placebo, and studied patients who had never received a biologic disease-modifying anti-rheumatic drug (bDMARD).
Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS, , also known as radiographic axial spondyloarthritis (axSpA). COAST-V is the first registration trial to use ASAS40 as the primary endpoint, compared to the standard endpoint of ASAS20, Lilly said.
AS is one type of spondyloarthritis that affects the pelvic joints and spine, and can be characterized by chronic inflammatory back pain, stiffness and impaired function and mobility. Of those affected by AS, approximately 80 percent will experience symptoms before age 30.2
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.
“At Lilly, the unmet needs of people living with autoimmune diseases drive our commitment to continue investing in novel science, developing medicines that may reduce the burden of disease and aim to raise the bar for treatment expectations,” Mallbris said.
In COAST-V, the incidence of treatment-emergent adverse events was similar with Taltz compared with placebo. The most common adverse events observed were consistent with the Phase 3 studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Lilly said it plans to submit detailed data from COAST-V for disclosure at scientific meetings and in peer-reviewed journals later this year.