AstraZeneca stops PhIIa trial of inhaled asthma drug with Pieris, cratering the Boston biotech’s shares

After culling a HER2 drug last summer to focus on an inhaled asthma med with AstraZeneca, Pieris Pharmaceuticals appears to be on thin ice with that program as well, as the Big Pharma ended a Phase IIa trial.

Stephen Yoder

AstraZeneca informed Boston-based Pieris yesterday that it will scrap a Phase IIa study of elarekibep after taking a look at safety findings from a non-clinical toxicology study. The dry powder inhaled formulation is also known as PRS-060/AZD1402 and is an IL-4 receptor alpha inhibitor.

Pieris will now “reassess our priorities and communicate a corporate update as quickly as possible following a thorough review of our options,” Pieris president and CEO Stephen Yoder said in a Wednesday morning press release.

In an SEC filing, Pieris said it will not share any more updates until it reviews the AstraZeneca decision and corporate priorities. The penny stock company’s shares $PIRS more than halved before the opening bell.

The biotech said the findings “are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.”

In the safety findings from a 13-week non-human primate study, AstraZeneca found that there was inflammation-mediated lung tissue damage, Pieris said.

William Blair analyst Matt Phipps said in a Wednesday morning note that the tissue damage was not dose-dependent and “we see no reason why this would be an on-target effect.”

“Therefore, the first assumption is an inflammatory response to the Anticalin backbone of elarekibep, which would have potential read-through to the company’s other inhaled Anticalin programs,” Phipps wrote. The drug is derived from a protein found in human tears and other tissues, known as lipocalin.

AstraZeneca planted $45 million upfront six years ago to get its hands on the program, whose timeline got delayed because of respiratory drug clinical trial disruptions during the Covid-19 pandemic. The topline results, expected in mid-2024, would have set up Pieris for an option to co-develop and co-commercialize the drug.

Pieris’ pipeline includes a wholly-owned, early-stage idiopathic pulmonary fibrosis trial and partnerships with Servier, Seagen, Boston Pharmaceuticals and a respiratory pact with Genentech.

As of March 31, Pieris had $48.4 million in cash, cash equivalents and investments, which would fund the biotech for more than 12 months, the company said on May 10.

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