Eli Lilly's ($LLY) closely watched autoimmune treatment met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.
The antibody, ixekizumab, works by blocking a cytokine called interleukin-17A, tamping down the inflammation at the heart of many autoimmune diseases. In a Phase III trial, Lilly tested two doses of the subcutaneous treatment against placebo in patients with psoriatic arthritis, and both ixekizumab groups demonstrated statistically significant improvements after 24 weeks, the company said.
On the safety side, Lilly said ixekizumab had a similar side effect profile as in earlier Phase III studies, where the most common adverse events were nasopharyngitis and injection site reaction. Lilly is disclosing only top-line data for now, saving full results for a later scientific meeting. The study will continue to evaluate ixekizumab's long-term efficacy for up to three years, Lilly said, and the company is working through a second Phase III psoriatic arthritis trial that began in December.
Ixekizumab's top target is psoriasis, against which the antibody has performed well in Phase III trials. Lilly plans to hand in an FDA application on that indication by the end of this quarter, pointing to pivotal data in which ixekizumab bested both placebo and the blockbuster Enbrel in clearing up psoriasis symptoms.
Lilly is one of many contenders in the competitive IL-17 space, led by Novartis ($NVS) and its psoriasis-treating secukinumab, approved in January as Cosentyx. Meanwhile, partners Amgen ($AMGN) and AstraZeneca ($AZN) are on pace to file their rival brodalumab this year, while Merck ($MRK) is working through Phase III with the IL-23-blocking tildrakizumab, and Johnson & Johnson ($JNJ) is doing the same for its similar guselkumab.
Like Lilly, each of the major psoriasis players is eyeing psoriatic arthritis as a secondary indication. Novartis is planning to file for approval in that disease this year, while the others are yet to disclose their timelines.
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