Pieris leading drug PRS220

Idiopathic pulmonary fibrosis (IPF) is the most common idiopathic interstitial pneumonia, a type of interstitial lung disease characterized by abnormal wound healing of the lungs, with progressive scarring and loss of lung function. IPF affects more than 3 million patients worldwide and approximately 130,000 patients in the United States. IPF not only affects the patient's quality of life (QOL), but also costs a lot of care. Given the potential for rapid progression of IPF and the associated risk of death, early diagnosis is important to maintain peak lung function and quality of life as long as possible. Significant advances in understanding the etiology of IPF have led to the development of new treatment options that improve outcomes, extend lifespan, and minimize the burden of illness on patients' daily lives. The magnitude of clinical efficacy for treatment costs has led to a lack of consensus on the cost-benefit analysis of drugs. Many treatment trial options are currently under development.

Data related to Pieris leading drug PRS220 were presented at the American Thoracic Society (ATS) International Conference 2022 in development to treat Idiopathic pulmonary fibrosis (IPF). PRS220 is an orally inhalable anticalin protein that targets connective tissue growth factor (CTGF), also known as CCN2, for the treatment of idiopathic pulmonary fibrosis (IPF). PRS220 is designed for inhalation via nebulizer. CTGF, a protein localized in the extracellular matrix, is a driver of fibrotic tissue remodeling as a result of abnormal wound healing. Overexpression of this target in lung tissue has been observed in patients suffering from IPF, and clinical data indicate that inhibition of CTGF reduces lung dysfunction in these patients. PRS220 binds dose dependently to CTGF, which is endogenously expressed by TGF-BETA1 activated NHLF (Normal human lung fibroblasts). The clinical development of the program is expected to begin in 2022 and it has been granted global commercial rights worldwide.

Along with PR220, PRS060 is also a Pieris' leading Anticalin based respiratory drug candidate developed in collaboration with AstraZeneca. PRS060 blocks IL4Rα immune receptors and inhibits IL4 and IL13 small proteins that promote a cascade of pulmonary inflammatory responses. Due to the small size and stability of the PRS060, it can be inhaled directly into the lungs instead of injecting the drug, providing the same benefits as systemic treatment, but with lower doses and fewer side effects. Phase I studies have shown significantly reduced levels of exhaled nitric oxide (FeNO), a biomarker of asthma, in patients with mild asthma. Currently this drug is in Phase IIa clinical trial. PRS 220 binds to CTGF with high affinity and maintains a more stable target binding compared to the anti-CTGF antibody pamrevlumab.

Pieris Pharmaceuticals focuses on corporate development and financing. This includes driving the company's business development efforts, expanding its current partnership assets, and investigating possible additional partnerships for the company's candidate drug portfolio. In Respiratory therapeutic landscape, Pieris Pharmaceuticals has an active partnership with global companies like AstraZeneca and Genentech.

Post-COVID

In the case of PRS220, Pieris Pharmaceuticals received a € 14.2 million grant from the Bavarian Ministry of Economy, Regional Development and Energy for research and development of the effects of SARSCoV2 infection (PASC) and pulmonary fibrosis (PASCPF) on post-acute consequences also known as pulmonary fibrosis after COVID19 syndrome.

The grant aims to support the evaluation of PRS 220 in PASCPF beyond the intended IPF population, including preclinical program activities and early clinical development including GLP toxicity studies, GMP manufacturing, and Phase 1 clinical development. The PRS220 goes through the nomination stage for drug candidates within the Pieris pipeline and presents several attributes that reflect best-in-class potential, including developmental profile showing suitability for inhalation delivery.