Phase III lebrikizumab trials meet all endpoints in AD

Lebrikizumab led to significant improvements with at least 75% skin clearance in more than half of people with moderate-to-severe atopic dermatitis (AD), as measured by EASI, in ADvocate 1 and ADvocate 2 Phase III clinical trials announced today by Spain’s largest drugmaker Almirall (ALM: MC), sending the firm’s shares up 4.4% to 14.35 euros by midday.

In the top-line results from these two monotherapy studies, primary and all key secondary endpoints, including skin clearance and itch improvement, were met at Week 16. Lebrikizumab is a novel monoclonal antibody (MAb) that binds soluble interleukin (IL)-13 with high affinity, has high bioavailability, a long half-life and blocks IL-13 signaling. The US Food and Drug Administration has granted Fast Track designation to lebrikizumab for moderate-to-severe AD in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg).

AD, also known as atopic eczema, is a chronic inflammatory skin disorder caused by skin barrier dysfunction and dysregulation of the immune response. According to a recent report from GlobalData, the AD space will see a total transformation over the next decade due to intense clinical activity.