Lilly Posts Top-Line Results From Psoriasis Drug Phase 3 Trial
Eli Lilly & Co. disclosed positive, top-line results from the Phase III trial showing that its drug ixekizumab was superior to both etanercept and placebo in clearing the skin of patients with moderate-to-severe plaque psoriasis.
Ixekizumab is a monoclonal antibody that specifically binds to and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A) implicated in psoriasis. IL-17A is a key factor in the buildup of excess skin cells which characterizes the disease. The drug is also in development for the treatment of psoriatic arthritis.
The drug met all primary and key secondary endpoints in the three UNCOVER pivotal Phase III studies. Ixekizumab demonstrated superiority to etanercept and placebo on skin clearance, which was measured by the Psoriasis Area and Severity Index (PASI) and the Static Physician Global Assessment (sPGA). The company noted that significant improvements were observed in as early as the first week of the trial and high levels of response to the ixekizumab treatment were maintained through the 60-week duration of the therapy.
David Ricks, Lilly SVP and president of Lilly Bio-Medicines, said, “These data are important for people suffering from moderate-to-severe plaque psoriasis, as up to 41 percent of those treated with ixekizumab were able to achieve clear skin at week 12, with just one injection per dose. These results give us confidence that if approved, ixekizumab could make complete resolution of psoriasis possible for significantly more people.”
Dr. Tom Bumol, SVP of biotech discovery research, Lilly Research Laboratories, and president, Applied Molecular Evolution, said, “These data appear to confirm our hypothesis — that IL-17A is a major driver of excess keratinocyte (skin cell) proliferation and activation in psoriasis. We're encouraged that this discovery by Lilly scientists could provide a new treatment option for patients with moderate-to-severe plaque psoriasis.”
Dr. Bumol said that ixekizumab is the most advanced asset in Eli Lilly’s pipeline of biotech-based drugs for autoimmune diseases. The investigational drug’s superiority to Amgen’s marketed psoriasis drug Enbrel positions it on the frontline of market competition for psoriasis treatments, Reuters reports. Another drug by Novartis labeled secukinumab also showed superiority to Enbrel in one study. Amgen is currently working with its partner AstraZeneca for a new anti-IL-17 drug labeled brodalumab, currently in late-stage development.
Lilly said it plans to file regulatory submissions of ixekizumab in the first half of 2015. If approved, the drug is forecasted to bring in annual sales of $600 million for the company by 2020.