Eli Lilly has announced that a phase III study evaluating the safety and efficacy of Taltz (ixekizumab) for the treatment of ankylosing spondylitis (AS) had positive results.
In the trial (COAST-V), Taltz met the primary and all key secondary endpoints and demonstrated a statistically significant improvement in the signs and symptoms of AS when compared to placebo.
Spondylitis is an inflammatory condition that affects the joints in the spine. It reduces the flexibility of the back and causes new bone to grow at the sides of the vertebrae. AS is a type of spondylitis that affects the pelvic joints and spine.
During the study, ixekizumab-treated participants received a starting dose of 80mg or 160mg, followed by one of two dosing regimens: either 80mg administered subcutaneously once every two weeks or 80mg administered subcutaneously once every four weeks.
The efficacy of the drug was measured by the proportion of participants who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) at week 16. ASAS40 means that AS patients improved at least 40% in three of four areas─patient global, pain, function and inflammation.
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By GlobalDataSo far only the top-line result against placebo has been published, but Lilly plans to submit detailed data from the trial for disclosure at scientific meetings and in peer-reviewed journals later in 2018.
“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 vice president and immunology platform team leader at Lilly Bio-Medicines Dr Lotus Mallbris.
“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.”
In December 2017, the US Food and Drugs Administration (FDA) approved Taltz for psoriatic arthritis. It also has FDA approval for the treatment of moderate-to-severe plaque psoriasis.
If approved for this indication, Taltz could compete with rival drug Cosentyx─ Novartis’s first-to-market blockbuster, which has forecast US sales of just under $1.1 billion by 2025, approved to treat psoriasis, AS, and psoriatic arthritis.
