Aiming for a new indication to expand the use — and sales — of its psoriatic arthritis drug Taltz, Eli Lilly is spotlighting positive Phase III results Thursday for its blockbuster hopeful against another type of arthritis: ankylosing spondylitis.
This form of spinal and large joint arthritis starts affecting patients before they turn 30 years old, causing inflammatory back pain, stiffness, and impaired mobility. Eli Lilly tested its drug alongside placebo in 300 patients with AS who didn’t respond well to one or two TNF inhibitors, which are often used to treat inflammation.
The company says Taltz (ixekizumab) scored on the primary and major secondary endpoints in the study, although details in its press release were scarce. Lilly used an ASAS 40 rating at 16 weeks for the primary endpoint in this new study, doubling the usual ASAS 20 mark.
Looking to revive flagging sales, Lilly gained a fresh approval to sell Taltz for psoriatic arthritis last December, opening up a US market with more than 1.5 million patients. It will be tough, however, for Lilly to compete in a field where Novartis $NVS continues to expand on longterm outcomes for patients with its first-to-market blockbuster Cosentyx.
Lotus Mallbris, Lilly’s vice president of immunology development, had this to say in a statement:
These positive results, in combination with previous results from the Phase III COAST-V study, provide further support for Taltz as a potential treatment option for patients with AS, including those who have had an inadequate response to treatment with TNF inhibitors, a difficult-to-treat population. By using ASAS40 as the primary endpoint in our clinical development program, we hope to establish a higher treatment target goal for AS patients. We look forward to sharing additional clinically meaningful data from this study and remain committed to continuing our research to evaluate potential treatment options that deliver better outcomes for patients living with this disease.
Lilly plans to showcase detailed trial data at scientific meetings and in peer-reviewed journals later this year. Based on results from the COAST-V and COAST-W studies, the company plans to file for US regulatory approval in AS later this year.
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