Projektbeschreibung
COVID-19: Neuer Wirkstoff Solnatide-IMP wird getestet
Die Coronavirus-Erkrankung-2019 (COVID-19) hat sich zu einer Pandemie mit Millionen Infizierten weltweit entwickelt. Erkrankte leiden unter schwerer Ateminsuffizienz und einem lebensbedrohlichen Lungenödem, das in 30 % aller Fälle zu akutem Lungenversagen führt. Im EU-finanzierten Projekt SOLNATIDE wird nun der neue Wirkstoff Solnatide-IMP an COVID-19-Patientinnen und -Patienten getestet. Solnatide hat bereits in einer klinischen Studie der Phase I und zwei Studien der Phase II Tests zur Behandlung von akutem Lungenversagen durchlaufen. Da es bisher kaum Wirkstoffe zur Behandlung von Patienten mit dem neuen Coronavirus gibt, bietet Solnatide eine vielversprechende Lösung, um die schweren Lungenprobleme einzudämmen, die von dem Virus ausgelöst werden.
Ziel
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’s 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 “treatment of pulmonary permeability oedema in patients with ARDS”. 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)
Wissenschaftliches Gebiet
Programm/Programme
Thema/Themen
Aufforderung zur Vorschlagseinreichung
H2020-SC1-PHE-CORONAVIRUS-2020
Andere Projekte für diesen Aufruf anzeigenFinanzierungsplan
RIA - Research and Innovation actionKoordinator
1080 Wien
Österreich
Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen).