AstraZeneca Halts Development of Inhaled IL-4Rα Antagonist Elarekibep, Pieris Pharmaceuticals' Stock Plummets by 71%

On June 21, Pieris Pharmaceuticals announced that it had received a decision from AstraZeneca to terminate the development of elarekibep. This decision was based on a 13-week non-clinical GLP toxicology study, which was unrelated to the ongoing clinical studies, but the results did not support the long-term use or late-stage clinical development of elarekibep. Following this news, Pieris' stock price fell by nearly 71%.

Elarekibep is an inhaled IL-4 receptor α inhibitor under development for the treatment of asthma. A 13-week non-human primate study conducted by AstraZeneca included three active dose groups. No clinical outcomes were observed at any dose, but there was lung tissue damage caused by inflammation-mediated effects independent of dose.

Currently, dupilumab is the only IL-4Rα monoclonal antibody approved globally, widely used for the treatment of asthma, atopic dermatitis, and other conditions, with sales reaching nearly 8.3 billion euros in 2022. In China, products developed by Connaught Biologics and Connect Biopharma have both entered Phase III clinical trials. Recently, Connaught Biologics stated that, according to the clinical protocol, it will continue to advance and collect long-term efficacy and safety data from the Phase III clinical study without recruiting more additional patients for data collection. Connaught Biologics noted that it will maintain ongoing communication with the Center for Drug Evaluation of the National Medical Products Administration to actively promote the marketing application of CM310 for the treatment of moderate-to-severe atopic dermatitis in adults.

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