According to Pieris Pharmaceuticals, AstraZeneca has stopped a Phase 2a trial of elarekibep (PRS-060/AZD1402), an inhaled IL-4 receptor alpha inhibitor that the companies were developing for the treatment of asthma. In the announcement, Pieris said that it has been informed by AstraZeneca that pathology results from a 13-week toxicology study of inhaled dry powder elarekibep in non-human primates indicated lung tissue damage, and those findings led AstraZeneca to stop the human trial.
Pieris stated that the toxicology findings “are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development” and added that it “will expedite a review of the implications of the data and AstraZeneca’s decision on the program and will review its overall corporate priorities prior to sharing a further update.” Pieris’s pipeline also includes PRS-220 inhalation solution, which is in Phase 1 development for the treatment of fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF).
AstraZeneca acquired development and commercialization rights to PRS-060, an Anticalin protein, in 2017. In May 2022, Pieris had warned of potential delays to the Phase 2 development program due to “the geopolitical situation, along with broader challenges amidst an ongoing pandemic.”
Pieris President and CEO Stephen Yoder commented, “We are disappointed with these non-clinical study results. Although elarekibep had begun enrolling in the efficacy portion of the Phase 2a study, later-stage development of this program requires supportive longer-term non-clinical toxicology data. We will now reassess our priorities and communicate a corporate update as quickly as possible following a thorough review of our options. We have greatly valued the expertise and resources AstraZeneca committed to elarekibep and are grateful to the many physicians, patients and caregivers who have supported this study.”
Read the Pieris Pharmaceuticals press release.
