Proteo Biotech AG Information

Proteo is focused on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Elafin for life threatening surgeries and life-threatening diseases such as pulmonary arterial hypertension (PAH). Proteo seeks partners and investors for the development, commercial scale manufacturing, marketing and distribution of the product. Elafin is identical to the human protein elafin with high specificity for tissue destroying and inflammation promoting proteases. Elafin has received orphan drug designations in the USA and the EU for ECS and PAH. So far, there were no safety concerns after the treatment of 75 patients in three randomized, double-blind, placebo-controlled clinical trials. Postoperative complications in major surgery are the most significant independent risk factor leading to high morbidity and hospital readmissions. Following the completion of two Phase II surgery trials in esophageal cancer surgery (ECS) and coronary artery bypass graft surgery, and a final European Medicines Agency advice letter, a European pivotal trial with Elafin in ECS is in preparation. Treatment of patients undergoing ECS resulted in a significantly shorter intensive care unit stay and a positive postoperative effect on liver and kidney markers. Treatment of patients undergoing coronary artery bypass surgery resulted in a postoperative reduction of the heart damage marker troponin I. In models of PAH it was shown that Elafin reverses obliterative changes in arteries of lung explants from PAH patients and that treatment with Elafin leads to the regression of pulmonary vascular lesions in rats. PAH is still a fatal disease with high medical need for therapies that stop disease progression. A Phase I trial in the US with subcutaneously administered Elafin is planned to commence with recruitment in 2019.