Pieris Pharmaceuticals Inc PIRS announced that partner AstraZeneca plc AZN decided to discontinue and cease dosing in the ongoing clinical studies of elarekibep, an inhaled IL-4 receptor alpha inhibitor under development for asthma.
The decision was based on lung findings from a non-clinical 13-week GLP toxicology study with dry powder inhaler-formulated elarekibep. The findings do not concern active clinical studies but do not support long-term use and progression to later-stage development.
AstraZeneca's decision was made independent of any data from the Phase 2a study. Pieris will expedite a review of the implications of the data and AstraZeneca's decision on the program and will review its overall corporate priorities before sharing a further update.
The 13-week non-human primate study included three active dose cohorts. AstraZeneca concluded that there were no clinical observations across any of the doses but that there were respiratory tract pathology findings.
These findings included inflammation-mediated lung tissue damage, which did not appear to be dose related.
In March, Pieris Pharma further pushback of the timeline for the readout from the Phase 2a study of elarekibep to mid-2024 from prior guidance of the third quarter of 2023.
AstraZeneca had communicated that completion of the Phase 2a study remains an important priority and that additional resources have been provided to achieve study completion.
Price Action: PIRS shares are down 56.10% at $0.38 on the last check Wednesday.
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