Eli Lilly has reported that its drug, lebrikizumab, provided substantial skin clearance in more than 50% of moderate-to-severe atopic dermatitis (AD) patients in Phase III ADvocate 1 and ADvocate 2 clinical trials.
An experimental monoclonal antibody, lebrikizumab attaches to interleukin-13 (IL-13) and hinders its signalling.
IL-13 is considered to play a major role in AD pathophysiology by inducing type 2 inflammation and mediating its effects on tissue.
In October 2019, Dermira commenced a Phase III programme comprising two identical trials of lebrikizumab for the treatment of moderate-to-severe AD.
The ongoing 52-week randomised, double-blind, placebo-controlled, parallel-group Phase III ADvocate 1 and ADvocate 2 trials are assessing lebrikizumab as monotherapy in adult as well as adolescent subjects aged 12 to 17 years with moderate-to-severe AD.
According to the top-line data from the trials, lebrikizumab met primary and all key secondary goals at week 16.
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The drug provided a minimum of 75% skin clearance in more than half of subjects with moderate-to-severe AD.
Lebrikizumab also provided early onset in skin clearance and itch relief, enhanced itch interference on sleep, and quality of life, which were some of the key secondary goals.
The occurrence of treatment-emergent adverse events (AEs) and serious AEs in lebrikizumab-treated patients was in line with those observed in the Phase II trial of the drug for AD.
Conjunctivitis, nasopharyngitis and headache were the most common AEs linked to the drug use, Lilly noted.
Eli Lilly immunology development vice-president Lotus Mallbris said: “Lebrikizumab is a specific inhibitor of IL-13 that offers robust binding affinity and high bioavailability.
“Today’s results show that the inhibition of IL-13 cytokine plays the main role in AD treatment, as demonstrated by more than half of the patients achieving at least 75% clearance to total clearance on lebrikizumab monotherapy.”
Lilly holds exclusive rights to develop and market lebrikizumab in the US and other parts of the world, except Europe.
Almirall licensed the rights to develop and commercialise the drug to treat dermatological indications, such as AD, in Europe.