Pieris Pharmaceuticals, Inc., a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, announced the development of PRS-220, an oral inhaled Anticalin protein targeting connective tissue growth factor (CTGF), also known as CCN2, for the treatment of idiopathic pulmonary fibrosis (IPF). The Company also announced it has been selected to receive a 14.2 million euros grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy for the research and development of PRS-220 for post-acute sequelae of SARS-CoV-2 infection (PASC) pulmonary fibrosis (PASC-PF), also known as post-COVID-19 syndrome pulmonary fibrosis or “long COVID”. Clinical development of the program for both indications is expected to begin next year.

PRS-220 follows Pieris’ strategy of deploying its proprietary Anticalin proteins for local interventions on clinically validated targets with the objective of developing superior medicines through more efficient biology. CTGF, a protein localized in the extracellular matrix, is a driver of fibrotic tissue remodeling as a consequence of an aberrant wound healing process. Over-expression of this target in lung tissue is observed in patients suffering from IPF, and clinical data indicate inhibition of CTGF reduces the decline in lung function among these patients. IPF affects over three million patients worldwide and roughly 130,000 patients in the United States. Mean survival is two to five years from the time of diagnosis, with standard of care conferring only modest benefit. The critical function of CTGF in fibrosis, as well as its induced expression upon tissue injury and fibrotic remodeling, render it a compelling intervention for PASC-PF. Persistent symptoms following severe COVID-19 have been reported by different studies in more than one third of hospitalized patients. Pathological changes include impairment of lung function and reduced diffusion capacity of lung for carbon monoxide (DLCO), as well as radiologically detected interstitial lung abnormalities indicative of fibrotic-like impairment of lung tissues. A sub-population of these patients is expected to benefit from an anti-fibrotic treatment, such as PRS-220. There is currently no approved therapy to address PASC-PF.

The grant announced, intended to support the evaluation of PRS-220 in PASC-PF beyond the intended IPF population, will support clinical-readiness activities and initial clinical development for the program, including GLP tox studies, GMP manufacturing, and phase 1 clinical development. PRS-220 has passed the drug candidate nomination stage within Pieris’ pipeline and has several features that reflect its best-in-class potential, including a developability profile demonstrating suitability for inhaled delivery. Pieris intends to present preclinical data for PRS-220 later this year, around which time the Company also plans to provide further program details in IPF and PASC-PF.

“The health consequences of the COVID-19 pandemic will affect our health system for a long time to come. Bavaria’s biotech and pharmaceutical companies are at the forefront of developing new therapies to combat the effects of this virus. Through the strategic grants of the Bavarian Ministry of Economic Affairs, we are providing financial support for particularly innovative therapeutic research projects. We are convinced of the great potential of the PRS-220 program and are therefore promoting its development through a grant of 14.2 million euros,” said Hubert Aiwanger, Bavarian State Minister of Economic Affairs, Regional Development and Energy.

“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. The Bavarian government’s support of innovative drug development is invaluable for both the local biotech ecosystem and broader public health initiatives, and we are grateful for having been selected as a recipient of this grant for PRS-220, which 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,” said Stephen S. Yoder, President and Chief Executive Officer of Pieris. “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.”