Almirall has announced that its phase 3 studies in atopic dermatitis show that lebrikizumab results in clearer skin for the majority of patients. The drug was used for patients with moderate-to-severe atopic dermatitis as part of Almirall’s Advocate programme.
The announcement was made at the American Academy of Dermatology (AAD) Annual Meeting and it was shared that more than 50% of patients with moderate-to-severe AD experienced at least a 75% reduction in disease severity at 16 weeks when receiving lebrikizumab monotherapy in the programme. Lebrikizumab also led to clinically significant improvements in itching and other patient-reported outcomes when compared to placebo.
The ADvocate programme is made up of two parts – ADvocate 1 and ADvocate 2. The ongoing 52-week global phase 3 studies are randomised, double-blind and placebo-controlled. They are designed to assess lebrikizumab as monotherapy in adult and adolescent patients – aged 12 to less than 18 years old and weighing at least 40kg – with moderate-to-severe atopic dermatitis.
In ADvocate 1, 43% of patients receiving lebrikizumab achieved clear or almost clear skin after 16 weeks compared to 13% of patients taking placebo. Among those receiving lebrikizumab, 59% achieved a 75% reduction in disease severity response, compared to 16% that received a placebo.
In ADvocate 2, 33% of patients taking lebrikizumab achieved clear or almost clear skin (IGA) after 16 weeks, compared to 11% of patients on placebo. Among those receiving lebrikizumab, 51% achieved a 75% reduction in disease severity response, compared to 18% that received a placebo.
After four weeks, patients receiving lebrikizumab had clearer skin and experienced less itching, and also experienced improved sleep and quality of life. The safety profile of the 16-week period was consistent with prior lebrikizumab studies in atopic dermatitis.
“New positive data from the phase 3 monotherapy studies ADvocate 1 and ADvocate 2 presented at the American Academy of Dermatology Annual Meeting demonstrate that lebrikizumab has the potential to be a leading treatment for a new generation of biologics. Patients need new treatment options that provide high efficacy and better tolerability,” said Karl Ziegelbauer, chief scientific officer at Almirall.
Almirall and Eli Lilly are expected to submit filings to regulatory bodies worldwide by the end of 2022, once the ADvocate studies have been completed. Almirall has licensed the rights to develop and commercialise lebrikizumab for the treatment of dermatology indications – including AD – in Europe, while Eli Lilly retains exclusive rights for development and commercialisation of lebrikizumab in the US and the rest of the world, outside Europe.