BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S – a global leader in medical dermatology – announced today that the first patient has been screened in the first head-to-head clinical trial to evaluate brodalumab (marketed in the European Union as Kyntheum®) compared with guselkumab (marketed globally as Tremfya®) in adult patients with moderate-to-severe plaque psoriasis who have an inadequate response to ustekinumab (marketed globally as Stelara®) treatment.
The COBRA (COmparing BRodalumab And guselkumab in ustekinumab inadequate responders) clinical trial is a randomized, double-blind, parallel-group, multinational study. The primary study endpoint is the proportion of patients who achieve PASI 100 (100% skin clearance) at week 16. The study further includes several secondary and exploratory endpoints, including the key secondary endpoint of time to PASI 100 response while on treatment for up to 28 weeks. PASI scores are used in clinical trials for psoriasis treatments to measure a change in disease severity.
“People with moderate-to-severe psoriasis benefit from complete skin clearance,” said Prof. Kristian Reich, Professor for Translational Research in Inflammatory Skin Disease at the University Medical Center Hamburg Eppendorf. “We have specifically designed this study to help understand which newer mechanism of action is the best option to help patients potentially achieve complete skin clearance when there is an insufficient response to older-generation biologics.”
Brodalumab is the only biologic treatment that selectively targets the interleukin-17 (IL-17) receptor subunit A.1 The IL-17 cytokines – a family of proteins involved in immune responses – send signals through the IL-17 receptors, which cause the inflammation associated with psoriasis.2
Guselkumab is a biologic treatment that selectively targets the interleukin 23 (IL-23) cytokine. IL-23 affects the differentiation, expansion, and survival of T cell subsets and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease.3
“We look forward to learning how brodalumab, in comparison with a treatment that targets the IL-23 pathway, can offer benefits to patients who no longer respond to less targeted therapies,” said Dr. Per Sproegel, Vice President, Medical Sciences, Global Research & Development, LEO Pharma.
NOTES TO EDITORS
About the pathophysiology of psoriasis
Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation.4 The discovery of the central role of the IL-23/type 17 T-cell axis in the development of psoriasis has led to major paradigm shifts in the pathogenic model for this condition.4 Medical research has further confirmed that the expression of IL-17 cytokines is increased in psoriatic lesion tissue.5
About LEO Pharma
The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. For more information about LEO Pharma, visit www.leo-pharma.com.
1 Campa M et al. Dermatol Ther 2016;6:1–12.
2 Armstrong A et al. J Drugs Dermatol 2019;18(8 Suppl 2):s202-208.
3 Tremfya Summary of Product Characteristics January 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf (Accessed September 2020).
4 Hawkes JA et al. J Allergy Clin Immunol. 2017;140:645–53.
5 Martin D et al. J Invest Dermatol 2013;133(1):17-26.