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Almirall shares positive topline results from atopic dermatitis trials

The company plans to submit a Marketing Authorisation Application to the EMA later this year


Almirall has revealed topline results from its one-year analysis of the efficacy and safety of its investigational IL-13 inhibitor, lebrikizumab, to treat patients with moderate-to-severe atopic dermatitis (AD).

While Almirall holds the licence to develop and commercialise lebrikizumab for the treatment of dermatology indications – including AD – in Europe, Eli Lilly retains the exclusive rights for development and commercialisation of lebrikizumab in the US and worldwide outside Europe.

AD, or atopic eczema, is a relapsing, chronic, heterogenous skin disease and is associated with intense itching, inflammation and dry skin.

Lebrikizumab is a novel, monoclonal antibody (mAb) that connects to the interleukin-13 (IL-13) protein, which is central in AD and can cause type 2 inflammation that exacerbates skin barrier dysfunction, itch and skin thickening, and can lead to infection.

The latest data taken from the ADvocate 1 and 2 phase 3 clinical trials showed eight out of ten patients who achieved clinical response – EASI-75 – with lebrikizumab monotherapy at 16 weeks, maintained skin clearance after a year of treatment. These studies are part of the clinical development programme for lebrikizumab in AD, assessing over 2,000 patients.

Patients involved in the two trials who were treated with lebrikizumab for a year continued to have relief from itching. The findings build upon positive data from the double-blind, 16-week, placebo-controlled arm of the ADvocate programme.

In ADvocate 1, 79% of patients who received lebrikizumab every four weeks and 79% of patients who received lebrikizumab every two weeks maintained 75% or greater skin improvement (EASI-75) after a year of treatment. In addition, 85% of patients who received lebrikizumab every four weeks and 77% of patients who received lebrikizumab every two weeks maintained EASI-75 response in ADvocate 2 after a year of treatment.

Karl Ziegelbauer, Almirall’s chief scientific officer, said: “We are pleased to witness how lebrikizumab has proven over a year its potential to be a leading option for the treatment of atopic dermatitis. ADvocate 1 and 2 results add to the exciting, growing body of evidence from our phase 3 clinical trial programme and demonstrate that this medicine may provide much-needed relief for those seeking new treatment options.”

Eli Lilly plans to submit an application to the US Food and Drug Administration (FDA) this year.

Article by
Fleur Jeffries

7th June 2022

From: Research, Regulatory, Healthcare



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