Pieris Pharmaceuticals has completed the safety review of the 10mg dry powder dose safety cohort from the Phase IIa trial of inhaler-formulated elarekibep (PRS-060/AZD1402) for the treatment of moderate-to-severe asthma.
An IL-4 receptor alpha inhibitor elarekibep is currently under development in partnership with AstraZeneca.
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The ongoing multi-centre, placebo-controlled study has examined the pharmacokinetics and safety profile of the dry powder formulation in 13 asthma patients who received elarekibep twice daily over four weeks along with medium dose inhaled corticosteroids with long-acting beta agonists.
AstraZeneca evaluated the changes in laboratory markers, incidence of adverse events and forced expiratory volume in one second against a placebo.
Topline data from the trial is expected by the middle of next year.
Pieris will also have a co-development option for this programme with AstraZeneca, upon completion of the Phase IIa study.
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By GlobalDataPieris president and CEO Stephen Yoder said: “We look forward to the completion of the Phase IIa study which, if successful, would serve as a key value inflection point in the development of this underserved, large market opportunity and will inform our decision to co-develop elarekibep alongside AstraZeneca.”
The safety review of the 10mg dose will further enable the company to evaluate elarekibep at doses of 10mg or less in its future trials.
Elarekibep is Pieris’ lead respiratory Anticalin-based drug candidate which is to be inhaled directly into the lungs.
