UCB’s bimekizumab demonstrated long-term maintenance of complete or almost complete skin disease resolution for psoriasis patients, according to results from the Phase 2b BE ABLE 2 Extension Study presented at the 2019 American Academy of Dermatology Annual Meeting (AAD) in Washington, DC. An investigational therapy, Bimekizumab selectively neutralizes IL-17F in addition to IL-17A.
In the BE ABLE 1 study, up to 79 percent of patients achieved at least 90 percent skin clearance (PASI90) as soon as week 12, based on a dose range of 64mg, 160mg, 160mg with a 320mg loading dose, 320mg, or 480mg, administered every four weeks. Among these BE ABLE 1 responders, defined as achievement of PASI90 at week 12, 80-100 percent maintained the rigorous PASI90 measure for up to an additional 48 weeks based on a dose range of 160mg or 320mg, administered every 4 weeks, in the BE ABLE 2 extension study.
Further, 70-83 and 78-100 percent of BE ABLE 1 responders maintained PASI100 and the Investigator's Global Assessment of response, respectively. The safety profile was consistent with previous studies, with no new safety findings observed. The most frequent treatment-emergent adverse events were oral candidiasis and nasopharyngitis. No cases of suicidal ideation/behavior, major adverse cardiac events, or inflammatory bowel disease were reported.
"The long-term results observed in the BE ABLE 2 Phase 2b study suggest the meaningful difference that IL-17F inhibition, along with IL-17A inhibition, can make for psoriasis patients who need significant, long-term skin clearance," says Andrew Blauvelt, MD, MBA, an investigator in the trial and President of Oregon Medical Research Center in Portland, Oregon, in a news release. "The results add to a growing body of evidence supporting the molecule's unique dual neutralization of both IL-17A and IL-17F cytokines across multiple inflammatory diseases, suggesting exciting potential."
"Despite recent advances in therapy, psoriasis patients still have profound unmet needs. Many patients do not experience long-term symptom resolution, and they often have limited confidence in long-term treatments. The positive results and rapid development of bimekizumab in psoriasis reflect UCB's dedication to connecting scientific innovation with greater patient value," adds Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB.
UCB is now validating these positive Phase 2b results with ongoing Phase 3 comparative studies of bimekizumab in psoriasis, and is studying it in other disease areas, including psoriatic arthritis and axial spondyloarthritis.