- Eli Lilly & Co. has in hand positive topline data from a Phase 3 study that evaluated its anti-inflammatory agent Taltz in a subset of patients with ankylosing spondylitis.
- Participants in the COAST-V trial who received Lilly's drug experienced significantly greater improvement in their disease signs and symptoms than those taking placebo. The trial also had a comparator arm, in which participants were given adalimumab, the active ingredient in AbbVie Inc.'s Humira. To enroll in COAST-V, patients must never have taken biological, disease-modifying, anti-rheumatic medication.
- Lilly expects to file Taltz for regulatory approval in the indication after the drug's late-stage program produces more data. Taltz is part of a wide-ranging class of therapies called interleukin (IL) inhibitors that includes Novartis AG's Cosentyx, Johnson & Johnson's Tremfya and Stelara, and Valeant Pharmaceuticals International Inc.'s Siliq.
There's not a lot of elbow room in the IL-inhibitor market, and especially as of late given how rapidly the Cosentyx (secukinumab) franchise is growing. Last year, Taltz (ixekizumab) notched $559 million worth of revenue, while Novartis' drug made almost quadruple that at $2.1 billion.
To be fair, Cosentyx gained approval more than a year ahead of Taltz. It has also pulled ahead in the indications department, securing nods from the Food and Drug Administration for plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. Taltz, meanwhile, carries just those first two indications — but Lilly is looking to even the score.
"A marker for the psoriatic arthritis opportunity would be to look at Cosentyx," Christi Shaw, president of Lilly Bio-Medicines, said during the company's fourth quarter earnings call in January. "Less than 40% of the scripts for Cosentyx are actually in the dermatology office, so we believe this is a really large opportunity in addition to the ankylosing spondylitis, and we expect that our uptake will be very similar to Cosentyx in [psoriatic arthritis] as we were in psoriasis."
"That market, we think, will be very large, and we think we’re competitive. We’re the only IL-17 that has in our label structure data as well as patients who have not responded well to [tumor necrosis factor]," she added.
Though COAST-V didn't enroll patients who had been treated with TNF inhibitors like Humira (adalimumab), another Phase 3 study — dubbed COAST-W — is evaluating how well TNF blocker-treated patients respond to Taltz. That trial has an estimated enrollment of 300 and a primary completion set for May.
In addition to the topline efficacy results, Lilly reported that treatment-emergent adverse events were similar between the Taltz and placebo arms of COAST-V. The Indianapolis-based drugmaker intends to present more complete data from the trial at medical conference in 2018 and to submit it to peer-reviewed journals as well.