AstraZeneca has discontinued and ceased dosing in the ongoing clinical studies of IL-4 receptor based on the lung findings from a non-clinical 13-week GLP toxicology study
Elarekibep is an inhaled IL-4 receptor alpha inhibitor under development to treat asthma complications. (Credit: Robina Weermeijer on Unsplash)
Pieris Pharmaceuticals has announced that its partner AstraZeneca stopped the clinical trials of its asthma candidate elarekibep after evaluating data from a toxicology study.
Elarekibep is an inhaled IL-4 receptor alpha inhibitor under development to treat asthma complications.
Pieris, a biotechnology company engaged in the production of new biotherapeutics using its proprietary Anticalin technology platform, licensed elarekibep to AstraZeneca in 2017.
AstraZeneca has discontinued and ceased dosing in the ongoing clinical studies of IL-4 receptor based on the lung findings from a non-clinical 13-week GLP toxicology study. The study was conducted with dry powder inhaler-formulated elarekibep.
The 13-week non-human primate study featured three active dose cohorts. The pharmaceutical major concluded that while there were no clinical observations at any of the levels.
Apart from that AstraZeneca found evidence of respiratory tract pathology. These findings included lung tissue damage caused by inflammation that did not seem to be dosage dependent.
Pieris president and CEO Stephen Yoder said: “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.”
The biotechnology firm said that the findings from the nonclinical tests are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.
The decision was made by AstraZeneca without reference to any Phase 2a research findings, which the firm conducted to assess the effect of IL-4 receptors on the lung function of adults with asthma.
Before providing further updates, Pieris said it will speed up an assessment of the data’s implications, AstraZeneca’s decision regarding the programme, and its broader business priorities.