Pieris Pharmaceuticals and AstraZeneca Present Single- Ascending Dose Phase 1a Data for Inhaled IL-4Rα Antagonist AZD1402/PRS-060 at the American Thoracic Society (ATS) 2019 International Conference

BOSTON, MA, USA I May 22, 2019 I 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 of placebo-controlled single ascending dose Phase 1a data for AZD1402/PRS-060, an inhaled IL-4Rα antagonist being developed in collaboration with AstraZeneca intended for the treatment of asthma, at the American Thoracic Society (ATS) 2019 International Conference.

The poster, titled "First-in-human data for the inhaled IL-4Rα antagonist AZD1402/PRS-060 reveals a promising clinical profile for the treatment of asthma," provides an overview of the results of the Phase 1a study, which demonstrated that AZD1402/PRS-060 was well tolerated when given as a single administered dose in 54 healthy volunteers. Forty-two volunteers received a nebulized dose ranging from 0.25mg to 400mg while 12 received an intravenous dose of 1mg or 2mg. AZD1402/PRS-060 is also being evaluated in a Phase 1b multiple-ascending dose study in mild asthmatics with elevated levels of fractional exhaled nitric oxide (FeNO), a validated biomarker of lung inflammation in asthma. The study will determine the local effects and dose relationship as measured by FeNO together with systemic exposure and overall safety and tolerability.

"We are encouraged by the safety and tolerability of AZD1402/PRS-060 in this Phase 1a study, the first Anticalin protein dosed via inhalation," said Louis Matis M.D., Chief Development Officer of Pieris Pharmaceuticals. "We look forward to completing and presenting the data from the multiple-ascending dose study, which will evaluate the FeNO-reducing potential of this drug candidate versus placebo, at an upcoming medical meeting."

A copy of the poster presentation is available on the publications section of the Pieris website.

About Pieris Pharmaceuticals

Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes an inhaled Anticalin protein to treat uncontrolled asthma, immuno-oncology multi-specifics tailored for the tumor microenvironment, and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin® is a registered trademark of Pieris. For more information, visit www.pieris.com.

SOURCE: Pieris Pharmaceuticals

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