Pieris Pharmaceuticals and AstraZeneca Present Multiple Ascending Dose Phase 1b Data for Inhaled IL4-Rα Antagonist AZD1402/PRS-060 at the 2019 European Respiratory Society International Congress
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BOSTON, MA / ACCESSWIRE / September 26, 2019 / 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 presentation on October 1, 2019, of interim data from its placebo-controlled multiple ascending dose phase 1b study for AZD1402/PRS-060, an inhaled IL4-Rα antagonist being developed in collaboration with AstraZeneca intended for the treatment of asthma, at the 2019 European Respiratory Society International Congress.
The poster, available on the Congress Website, is titled "Multiple ascending dose study of the inhaled IL-4Rα antagonist, AZD1402/PRS-060, in mild asthmatics demonstrates robust FeNO reduction and a promising clinical profile for the treatment of asthma," and reported that AZD1402/PRS-060 was safe and well tolerated at all doses, significantly reduced fractional exhaled nitric oxide (FeNO) - a validated biomarker or eosinophilic airway inflammation, and showed dose-dependent systemic target engagement in patients with mild asthma and elevated levels of FeNO (≥ 35ppb). During the treatment period, 30 patients were randomized to receive delivered doses of AZD1402/PRS-060 ranging from 2mg to 60mg (5mg to 150mg administered through a nebulizer) twice a day for nine consecutive days and one final dose on the 10th day, and 12 patients were randomized to receive placebo at the same time points.
Significant and pronounced inhibition of FeNO relative to placebo was observed at all doses. When comparing the 20mg AZD1402/PRS-060 powered cohort (n=12) versus placebo, the primary statistical analysis using the emax model demonstrated a 36% relative reduction in FeNO (Figure 1). Systemic target engagement was dose-dependent and closely aligned with systemic exposure of the drug, consistent with results of the Phase 1a single ascending dose study. No systemic target engagement and minimal systemic exposure was observed at the 2mg dose, suggesting that local target engagement by the drug is sufficient to reduce airway inflammation.