Eli Lilly Releases Positive Phase 3 Study Results for its Antibody
The antibody, Mirikizumab, met the primary and all key secondary endpoints versus placebo at Week 16 and all key secondary endpoints versus Cosentyx at Week 16 and Week 52.
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By - Eli Lilly and Company recently announced that its monoclonal antibody, mirikizumab, showed promise in its Phase 3 study for patients with moderate to severe plaque psoriasis.
Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. The study showed that mirikizumab met the primary and key secondary endpoints versus placebo and all secondary endpoints, versus Consentyx (secukinumab) at week 16.
The OASIS-2 study is a randomized, double blind, placebo-controlled study comparing the safety and efficacy of mirikizumab to a placebo and Consentyx in patients with plaque psoriasis.
The safety profile was consistent with previously disclosed results for mirikizumab and known safety findings of other drugs in the IL23p19 class.
"The results from this study are promising to people around the world who are burdened by psoriasis,” Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines, said in a statement “Lilly is grateful to the patients, providers and investigators for advancing science to benefit patients with immunologic conditions."
"We look forward to bringing mirikizumab to market to provide patients with an additional treatment option that has the potential to provide near complete or complete skin clearance as measured by PASI 90 and PASI 100, with sustained results at 52 weeks,” he added.
The most common adverse events, which were seen in less than 5 percent of patients, and included nasopharyngitis and upper respiratory infections up to week 16.
At baseline to week 52, nasopharyngitis, upper respiratory tract infections, headache, back pain, and arthralgia were common.
Researchers uncovered the primary endpoints based on the proportion of patients with Static Physician’s Global Assessment (sPGA) of (0,1) with at least a 2- point improvement.
Additionally, they looked at the proportion of patients with at least a 90 percent improvement from the baseline in Psoriasis Area and Severity Index (PASI 90) at Week 16, compared to the placebo or to Consentyx.
Other key secondary endpoints compared to the placebo at Week 16 included the number of patients with at least a 75 and 100 percent improvement from baseline in PASI 90.
At Week 52, key secondary endpoints compared to Cosentyx included the proportion of patients with a sPGA of (0,1) and at least a 2-point improvement, as well as the number of patients with at least a 90 and 100 percent improvement from baseline in PASI 90.
In addition to mirikizumab in psoriasis, researchers also studied the antibody for the treatment of ulcerative colitis and Chron’s disease. Lilly expects topline results for the Phase 3 induction data in ulcerative colitis in the spring of 2021 and for the Phase 3 Crohn's data in 2022.
"We are pleased with the positive results observed in the mirikizumab psoriasis development program (OASIS). Mirikizumab has the potential to be a meaningful treatment option for people living with psoriasis," said Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center and a lead investigator in the OASIS program, in a statement.
"The data builds on our understanding of IL-23 inhibition in psoriasis and possible future applications," he added.
Currently, Eli Lilly is also studying other treatments for atopic dermatitis and alopecia areata, a disease without an FDA-approved treatment.
