Almirall: Lebrikizumab Dosed Every Four Weeks Maintained Durable Skin Clearance in Phase 3 Monotherapy Atopic Dermatitis Trials

• New, late-breaking data show lebrikizumab responders reported long-lasting results at one year of treatment across measures of improvement in skin clearance, itch and disease extent and severity
• Results suggest less frequent, every four week dosing of lebrikizumab provided similar improvements to every two week dosing
• Regulatory submissions for EU and U.S. planned for this year

BARCELONA, Spain, Sept. 8, 2022 /PRNewswire/ --  Almirall, S.A. (ALM), a global biopharmaceutical company focused on skin health, today announced new detailed results from Phase 3 monotherapy studies in atopic dermatitis (AD) which showed investigational lebrikizumab provided robust and durable improvements in skin clearance and itch for patients who achieved a clinical response* at Week 16 through one year of treatment. Lebrikizumab, a high-affinity and potent IL-13 inhibitor, delivered similar results when dosed once every four weeks or once every two weeks after Week 16. These data were featured in a late-breaking, oral presentation at the 31st European Academy of Dermatology and Venerology (EADV) Congress. The company previously announced topline results of these one-year analyses of ADvocate 1 and ADvocate 2 in June 2022. 

"AD is a debilitating chronic disease that requires effective treatment options that, in addition to achieving skin clearance and control of symptoms, can improve the quality of life of those patients who suffer it. The encouraging data from the ADvocate trials demonstrate how lebrikizumab maintained response in skin clearance, disease severity and symptoms such as itch independent of the dosing scheme tested after the induction period. Lebrikizumab, which acts directly on the IL-13 key cytokine, opens the door to a new, well-tolerated treatment option that can provide long-term disease control," said Jacob Thyssen, MD PhD DmSci, Professor at University of Copenhagen, dermatologist at Bispebjerg Hospital and senior author of the ADvocate analyses.

Efficacy with every four week dosing, after a 16-week induction period with lebrikizumab every two weeks, was similar to that of every two week dosing.

In ADvocate 1, lebrikizumab demonstrated the following results:

• 74% of patients dosed every four weeks and 76% of patients dosed every two weeks maintained clear or almost clear skin (IGA 0 or 1) at one year of treatment.
• 79% of patients dosed every four weeks and 79% of patients dosed every two weeks maintained 75% or greater skin improvement (EASI-75) at one year of treatment.
• 80% of patients dosed every four weeks and 81% of patients dosed every two weeks maintained clinically meaningful reductions in itch at one year of treatment, as measured by a four-point or larger reduction in itch severity on the Pruritus Numerical Rating Scale (NRS).

In ADvocate 2, lebrikizumab demonstrated the following results:

• 81% of patients dosed every four weeks and 65% of patients dosed every two weeks maintained clear or almost clear skin (IGA 0 or 1) at one year of treatment.
• 85% of patients dosed every four weeks and 77% of patients dosed every two weeks maintained EASI-75 response at one year of treatment.
• 88% of patients dosed every four weeks and 90% of patients dosed every two weeks maintained clinically meaningful reductions in itch at one year of treatment, as measured by a four-point or larger reduction in itch severity on the Pruritus NRS.

Safety among patients at 52 weeks was consistent with the induction phase of the trials and prior lebrikizumab studies in AD. The incidence rate of treatment-emergent adverse events remained stable over time in patients with lebrikizumab. The proportion of lebrikizumab-treated patients who reported an adverse event in ADvocate 1 and ADvocate 2 through Week 52 was 58% and 68%, respectively. Most adverse events across the two studies were mild or moderate in severity, nonserious and did not lead to treatment discontinuation. The most commonly reported adverse events were conjunctivitis, common cold and headache.

"The detailed data that were presented today at EADV demonstrate the potential benefit that lebrikizumab could bring to HCPs and patients. Living with atopic dermatitis means facing a complex condition that impacts quality of life and overall wellbeing. At Almirall, we are determined to find life-changing treatments for every patient, and we are convinced that, once approved, we will be bringing to market a promising first-line advanced systemic treatment for moderate-to-severe AD that offers robust and durable efficacy with less frequent dosing," said Karl Ziegelbauer, Ph.D., Almirall's Chief Scientific Officer.

Full results from the Phase 3 studies will be published in a peer-reviewed journal. Almirall and Eli Lilly and Company plan to submit regulatory applications to European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) respectively for lebrikizumab in AD this year. The FDA granted lebrikizumab Fast Track designation in AD in December 2019.

"Based on the robust and clinically meaningful results from our clinical trial program in atopic dermatitis, we believe lebrikizumab, if approved, could become an important treatment for dermatologists and many of their patients with moderate-to-severe disease who suffer from debilitating symptoms and seek new options," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly. 

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside Europe.

^*Responders were defined as those achieving a 75% reduction in the Eczema Area and Severity Index from baseline (EASI-75) or an IGA 0 or 1 ("clear" or "almost clear") with a 2-point improvement and without rescue medication use at Week 16. At Week 16, responders were re-randomized to lebrikizumab 250 mg every two weeks or four weeks or placebo for an additional 36 weeks.

Further information on the press release of the phase 3 monotherapy studies of lebrikizumab at: https://www.almirall.com/media/newsroom

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