Pieris Pharmaceuticals Announces Successful Completion of Safety Review for 10 mg Dose of Phase 2a Trial of Elarekibep (PRS-060/AZD1402)
Excerpt from the Press Release:
BOSTON, MA / ACCESSWIRE / May 4, 2023 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced the successful safety review of the 10 mg dry powder dose safety cohort from the ongoing multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated elarekibep (PRS-060/AZD1402). The successful review of the 10 mg dose provides additional data supporting the elarekibep safety profile and enables doses of 10 mg or less to be evaluated in future clinical trials.
Elarekibep is an IL-4 receptor alpha inhibitor under development in collaboration with AstraZeneca for the treatment of moderate-to-severe asthma. Pieris previously announced the successful completion of the safety review for the 1 mg and 3 mg doses, triggering the efficacy portion of the study, which is ongoing at the 3 mg dose. Upon completion of the phase 2a study and availability of topline data, which Pieris expects to be reported by mid-2024, the Company will have a co-development option for this program with AstraZeneca.
For this safety review, 13 asthma patients, controlled on standard of care (medium dose inhaled corticosteroids with long-acting beta agonists), received elarekibep twice daily over four weeks to establish the safety profile and pharmacokinetics of the dry powder formulation of elarekibep at the 10 mg dose. Following completion of enrollment and observation, AstraZeneca evaluated, compared to placebo, the incidence of adverse events, changes in laboratory markers (immuno-biomarkers, clinical chemistry, and hematology), and forced expiratory volume in one second.
“The successful safety review for the elarekibep 10 mg dose cohort provides another data point supporting the potential for this program. Elarekibep offers the potential to significantly improve the standard of care for asthma patients with a superior product profile,” said Stephen S. Yoder, President and Chief Executive Officer of Pieris.
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