The company announced that at week 16, more than 83% of patients dosed with Ebglyss no longer required the use of concomitant therapies such as topical corticosteroids. Credit: Shutterstock / Kmpzzz.
Eli Lilly’s Ebglyss (lebrikizumab-lbkz) has achieved complete skin clearance after three years in 50% of patients with moderate-to-severe atopic dermatitis (AD) in a Phase III trial.
The US company has said that its long-term safety ADjoin study (NCT04392154), examining its interleukin-13 (IL-13) inhibitor that blocks the primary cytokine responsible for inflammatory skin condition, also saw 87% of patients achieving ‘almost-clear’ skin as measured by the Eczema Area and Severity Index (EASI).
Additionally, the company announced that at week 16, more than 83% of patients dosed with Ebglyss no longer required the use of concomitant therapies such as topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) for the duration of the study.
The company now plans to unveil the full results from the three-year study as part of the American Academy of Dermatology (AAD) Annual Meeting today (10 March).
Eli Lilly’s immunology development senior vice president Mark Genovese said: “We hear from patients with moderate-to-severe AD that they struggle with recurring and unpredictable flares and are looking for treatment options that can provide long-term disease control.
“Ebglyss is the only first-line biologic treatment option for patients with disease uncontrolled by topicals to report completely clear skin at three years with a once-monthly maintenance dose. The additional assessments presented at AAD demonstrate significant improvements in disruptive symptoms, such as itch, across a range of patient groups.”
The Phase III monotherapy trial ran for 152 weeks recruiting 1,188 patients across 321 international sites who had previously completed the company’s ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967) monotherapy trials. Patients received a maintenance dose of 250mg of Ebglyss either every two weeks or once monthly.
At the same time, the company has announced that it plans to announce results from its additional Phase IIIb ADmirable trial (NCT05372419) examining Ebglyss in patients with skin of colour and moderate-to-severe AD. In that trial, 68% of people experienced a significant improvement of at least 75% in disease extent and severity, whilst 46% of people experienced at least a 90% improvement.
Center for Medical Dermatology and Immunology Research director Raj Chovatiya said: “Healthcare providers are constantly searching for ways to help patients achieve deep, sustainable improvement in the signs and symptoms of their AD.
“This three-year data show that raising the bar in AD treatment to long-term total skin clearance was an achievable treatment goal for at least half of Ebglyss week 16 responders, reinforcing its efficacy as a first-line biologic treatment for people with moderate-to-severe AD uncontrolled by topicals.”
Eli Lilly received approval from the US Food and Drug Administration (FDA) for Ebglyss in AD in September 2024. The drug had already received approval for use in the European Union (EU) on 16 November 2023.
GlobalData predicts that Ebglyss will reach blockbuster status in 2027 and bring in $2.49bn in 2030.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of dermatology, Bambusa Therapeutics has announced the dosing of its first healthy volunteers as part of a Phase I trial on its half-life extended bispecific antibody therapy for AD. Meanwhile, Palvella Therapeutics is set to expand its 24-week Phase III SELVA trial to include subjects aged three to five years old for evaluating Qtorin.
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