Eli Lilly and Company (NYSE: LLY) has disclosed findings from a pioneering investigation into lebrikizumab, tailored specifically for individuals with skin of color grappling with moderate-to-severe atopic dermatitis, commonly known as eczema. The study unveiled that lebrikizumab, an investigational treatment, led to enhancements in skin clearance and alleviation of itching. These findings, presented at the American Academy of Dermatology (AAD) Annual Meeting, stem from a Phase 3 trial.
The efficacy outcomes of lebrikizumab from this trial mirror data from other Phase 3 trials, indicating its potential as a primary biologic treatment post-topical prescription therapies for individuals across various skin tones suffering from moderate-to-severe atopic dermatitis.
Dr. Andrew Alexis, lead study investigator and Professor of Clinical Dermatology at Weill Cornell Medicine, highlighted the disproportionate impact of atopic dermatitis on people with skin of color and the historical underrepresentation of this demographic in clinical trials. These initial findings mark a significant step towards addressing the needs of individuals with skin of color affected by atopic dermatitis.
The study, which assessed 50 patients with moderate-to-severe atopic dermatitis and darker skin tones, revealed promising results after 16 weeks of treatment with lebrikizumab. Key findings include:
- 68% of participants experienced significant improvement of at least 75% in disease extent and severity (EASI-75).
- 46% experienced at least 90% improvement in disease extent and severity (EASI-90).
- 39% achieved clear or almost clear skin (IGA 0,1) with a reduction of at least two points from baseline.
- 55% experienced clinically meaningful itch relief (PNRS ≥4-point improvement).
Moreover, the study observed no new safety signals or serious adverse events. The study also featured a physician assessment of changes in post-inflammatory pigmentation.
Dr. Mark Genovese, Senior Vice President of Immunology Development at Lilly, emphasized the significance of these findings, particularly for individuals with skin of color who face barriers to treatment.
Lilly remains committed to advancing health equity in dermatology by engaging in impactful research, supporting healthcare providers, and empowering patient voices. Efforts to involve a more diverse range of participants in clinical trials continue to be a priority for Lilly.
Lebrikizumab is under exclusive development and commercialization by Lilly in the U.S. and the rest of the world outside Europe, where rights have been licensed to Almirall S.A. for dermatology indications, including eczema.
The study referred to as ADmirable (NCT05372419) is a Phase 3b, open-label, 24-week study evaluating lebrikizumab’s safety and efficacy in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis. Interim data from the study, analyzed at 16 weeks, showcased promising outcomes.
Lebrikizumab is an investigational monoclonal antibody targeting IL-13, which plays a pivotal role in atopic dermatitis. The Phase 3 program for lebrikizumab encompasses various global studies, with further data anticipated to be released in late 2024.
