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

Objective

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)

Field of science

  • /medical and health sciences/health sciences/infectious disease/RNA virus/coronavirus

Call for proposal

H2020-SC1-PHE-CORONAVIRUS-2020
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

RTDS - VEREIN ZUR FORDERUNG DER KOMMUNIKATION UND VERMITTLUNG VON FORSCHUNG, TECHNOLOGIE UND INNOVATION (RTDS VEREIN, ENGL. RTDS ASSOCIATION)
Address
Lerchengasse 25/2-3
1080 Wien
Austria
Activity type
Other
EU contribution
€ 132 228,75

Participants (4)

OPIS SRL
Italy
EU contribution
€ 365 833,34
Address
Via Matteotti 10
20832 Palazzo Aliprandi
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
Germany
EU contribution
€ 150 000
Address
Geschwister Scholl Platz 1
80539 Muenchen
Activity type
Higher or Secondary Education Establishments
BCN PEPTIDES SA
Spain
EU contribution
€ 310 937,50
Address
Carretera Comarcal C-244 Km 22 Poligon Industrial Els Fogars Sector Ii
08777 Santa Quinti De Mediona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
APEPTICO FORSCHUNG UND ENTWICKLUNG GMBH
Austria
EU contribution
€ 667 025,41
Address
Mariahilferstrasse 136 Top 1.15
1150 Wien
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)