Exploration of safety, tolerability and clinical efficacy of Solnatide IMP in patients infected with the 2019 new coronavirus

Clinical features of patients infected with the 2019-nCoV have revealed that these patients suffer from severe respiratory failure, and presence of a life-threatening pulmonary oedema (PPO). Approx. 30% of 2019-nCoV-patients further develop life-threatening Acute Respiratory Distress Syndrome (ARDS). Mortality rate of these patients is very high. Initiator and Scientific Coordinator of the project, APEPTICO, is a SME biotechnology company (EMEA/SME/012/09) developing peptide-based products targeting life-threatening pulmonary diseases, including oedematous respiratory failure, acute lung injury, primary graft dysfunction, high altitude pulmonary oedema and PHA type 1. APEPTICO'Äôs lead-compound Solnatide (INN) has been designed for the therapeutic treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and various forms of life-threatening Pulmonary Oedema (PPO). Orally inhaled Solnatide has delivered clinical proof-of-concept in one Phase I, and in two Phase II clinical studies (EUDRACT No. 2011-000223-33, 2012-001863-64, 2013-000716-21). Today, no medicine has been approved for the therapeutic treatment of Pulmonary Permeability Oedema and ARDS. Currently, Solnatide is subject to a Phase IIB trial (EUDRACT No. 2017-003855-47) for the 'Äútreatment of pulmonary permeability oedema in patients with ARDS'Äù. The Phase IIB clinical trial has been approved by the German and the Austrian Competent Authorities, as well by Ethic Committees of leading Medical University Hospitals in Germany as well Austria. Most recently, APEPTICO has entered into a partnership with HAISCO Pharmaceutical Group in Chengdu, Sichuan, P.R. China. HAISCO has access to core areas and leading Medical University Hospitals in the P.R. China. Accordingly, APEPTICO proposes to immediately apply the Solnatide IMP for the treatment of patients infected with the 2019-nCoV and to demonstrate safety, tolerability and clinical efficacy of Solnatide IMP in 2019-nCoV patients. The overall project coordination and external communications is by RTDS Association (www.rtds-group.com/association)