AstraZeneca has dosed the first subjects in three clinical trials of monoclonal antibody Fasenra (benralizumab) for the treatment of skin diseases.
The studies include one Phase III clinical trial in bullous pemphigoid (BP) and two Phase II studies in atopic dermatitis (AD) and chronic spontaneous urticaria (CSU ).
In-licensed from Biowa , Fasenra attaches to IL-5 receptor alpha on eosinophils and draws natural killer cells to trigger apoptosis for quick and near-complete blood and tissue eosinophil depletion.
AstraZeneca is currently assessing the antibody in nine Phase II and Phase III trials in patients with eosinophilic immune dysfunction (EID) diseases, excluding severe asthma.
The Phase III FJORD trial is assessing the efficacy and safety of Fasenra in patients with BP.
The Phase II HILLIER trial and the Phase II ARROYO trial are analysing the efficacy and safety of benralizumab in moderate to severe AD and moderate to severe CSU, respectively.
Data readout from these three trials is anticipated after next year.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “These trials may provide future treatment options as we follow the science to better understand the role of eosinophils in these often debilitating skin diseases.
“This progress is yet another important step towards our ambition to bring Fasenra to patients beyond severe asthma, through our extensive clinical programme covering a broad range of dermatological, gastrointestinal and systemic inflammatory illnesses.”
Fasenra is also being studied in a Phase III RESOLUTE study for severe chronic obstructive pulmonary disease (COPD) treatment, OSTRO and ORCHID trials for chronic rhinosinusitis with nasal polyps, a MESSINA trial for eosinophilic esophagitis, and a NATRON trial for patients with hypereosinophilic syndrome.
The antibody is also being analysed in Phase III MANDARA and HUDSON trials for treating patients with eosinophilic granulomatosis with polyangiitis and eosinophilic gastritis/eosinophilic gastroenteritis, respectively.
Fasenra is approved as an add-on maintenance therapy for severe eosinophilic asthma in countries, including the US, EU, and Japan.
In January last year, AstraZeneca started three new clinical trials to evaluate Fasenra for the treatment of eosinophil-driven skin diseases.