Inhaled PRS-220 Aims to Treat Both IPF and ‘Long COVID’ PF

Pieris Pharmaceuticals plans to start clinical development of PRS-220 in 2022 for idiopathic pulmonary fibrosis (IPF) — and also will advance the investigative, inhaled therapy for “long COVID” PF, or post-COVID-19 pulmonary fibrosis, the company said.

The clinical development of PRS-220 for long COVID pulmonary fibrosis will be supported by grant of more than €14 million (nearly $17 million) from Germany’s Bavarian Ministry of Economic Affairs, Regional Development and Energy.

“This grant for PRS-220 … will allow us to accelerate its development and broaden clinical investigation beyond IPF to address an evolving medical need precipitated by the global COVID-19 pandemic that we believe will persist,” Stephen S. Yoder, Pieris’ president and CEO, said in a press release.

Further details on the IPF program, as well as PRS-220 preclinical data, are expected to be provided by Pieris later this year. According to the pharmaceutical, based in Boston in the U.S., and in Hallbergmoos, in Germany’s Bavaria state, clinical development of PRS-220 for both indications is expected to begin in 2022.

“We are excited to unveil our most advanced proprietary inhaled respiratory program and look forward to sharing more details on this program later this year, while actively working to begin clinical development next year,” Yoder said.

Pieris aims to use its proprietary Anticalin technology platform to develop more efficient and specific interventions on clinically validated targets for respiratory diseases, cancer, and other indications.

Anticalin proteins are small, stable, modular, and inhalable molecules derived from human lipocalins — proteins that naturally transport molecules throughout the body.

Because these lipocalins are smaller than conventional protein or antibody therapeutics, they have potential for greater target tissue penetration and delivery through non-injectable routes, such as inhalation. In addition, the researchers noted, Anticalin proteins can be linked to each other or to other therapeutic molecules to form multi-specific and multifunctional therapy candidates.

PRS-220 is an Anticalin protein designed to bind and block the activity of connective tissue growth factor (CTGF), a protein known to contribute to the progressive and excessive tissue scarring (fibrosis) characteristic of IPF and other fibrotic diseases.

By blocking CTGF, PRS-220 is thought to prevent the activation of downstream pro-inflammatory and pro-fibrotic factors. It potentially represents an antifibrotic treatment that directly tackles the underlying mechanism of IPF.

Importantly, data from previous clinical trials with other CTGF-targeting therapies — delivered directly into the bloodstream — showed that such an approach can effectively reduce lung function decline in people with IPF.

Given CTGF’s role in fibrotic conditions, the developer believes PRS-220 also may be a promising therapy for post-COVID-19 pulmonary fibrosis, also known as post-acute sequelae of SARS-CoV-2 infection pulmonary fibrosis (PASC-PF), or “long COVID.”

Reported in more than a third of hospitalized patients who have recovered from COVID-19 infection, the condition is characterized by persistent symptoms reflected by reduced lung function and fibrotic-like abnormalities in the lungs.

“The health consequences of the COVID-19 pandemic will affect our health system for a long time to come,” said Hubert Aiwanger, the Bavarian state minister of Economic Affairs, Regional Development and Energy. “Bavaria’s biotech and pharmaceutical companies are at the forefront of developing new therapies to combat the effects of this virus.”

There currently is no approved therapy for PASC-PF, and a subpopulation of these patients is expected to benefit from an anti-fibrotic treatment like PRS-220, according to Pieris.

To aid in the clinical development of PRS-220, the Bavarian ministry has awarded Pieris a €14.2 million grant (about $16.9 million).

“Through the strategic grants of the Bavarian Ministry of Economic Affairs, we are providing financial support for particularly innovative therapeutic research projects,”  Aiwanger said, adding, “We are convinced of the great potential of the PRS-220 program.”

Yoder said the government’s support “is invaluable for both the local biotech ecosystem and broader public health initiatives.”

“Pieris is a pioneer in the inhaled biologics space, and it is gratifying to leverage our respiratory platform to improve the lives of those affected by respiratory diseases such as IPF and COVID-19,” he said.