Exploration of safety, tolerability and clinical efficacy
of solnatide IMP in patients infected with the 2019 new Coronavirus
During the SOLNATIDE project a therapeutic peptide – APEPTICO’s lead-compound solnatide (IMP) – which successfully targets severe pulmonary diseases (such as ARDS, PPO, oedematous respiratory failure or acute lung injury), is clinically tested for treatment of the life-threatening effects of an infection with COVID-19.
H2020 | Coronavirus
€ 1.64 million
The main impacts
SOLNATIDE develops a first-ever therapeutic medicine for the therapeutic treatment of patients with life-threatening pulmonary dysfunction, to decrease mortality and to improve the quality of life for surviving patients, especially in the context of the COVID-19 outbreak.
The treatment of COVID-19 patients with the therapeutic peptide solnatide IMP developed within the SOLNATIDE project could significantly impact the treatment: shortening time spent in ICU, shortening time on respirators, alleviate main disease symptoms, and in some cases even enable patients’ survival until further treatment such as a lung transplant is available.
In addition, there exist other known and unknown viruses and agents that may cause life threatening pulmonary permeability oedema (PPO) and Acute Respiratory Distress Syndrome (ARDS) in patients. The completion of our state-of-the-art development of the Solnatide peptide drug will strengthen our competitiveness and growth of APEPTICO by applying know-how, IPR and gained experience to even more and new peptide drug developments.
The SOLNATIDE project will clinically test peptide-based products targeting life-threatening pulmonary diseases (e.g. oedematous respiratory failure, acute lung injury). APEPTICO’s lead-compound Solnatide (IMP) has been designed for the therapeutic treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and various forms of Pulmonary Oedema (PPO).
Orally inhaled Solnatide has delivered clinical proof-of-concept in 1 Phase-I and 2 Phase-II clinical studies (EUDRACT No. 2011-000223-33, 2012-001863-64, 2013-000716-21). Currently, Solnatide is subject to a Phase IIB trial (EUDRACT No. 2017-003855-47) with clinical trials approved by competent authorities and ethics committees in Germany and Austria. The SOLNATIDE project will generate clinical trial results assessing safety, tolerability and clinical efficacy of Solnatide IMP in COVID-19 patients.
Patients infected with the new Coronavirus (2019-nCoV, Covid-19) suffer from severe respiratory failure, and presence of a life-threatening pulmonary oedema (PPO). Approximately 30% of Covid-2019 patients further develop life-threatening Acute Respiratory Distress Syndrome (ARDS) resulting in a very high mortality rate.
To date, no medicine has been approved for the therapeutic treatment of Pulmonary Permeability Oedema and ARDS. As such immediate medical exploitation and clinical use of the Investigational Medicinal Product Solnatide will be deployed.
This project has received funding from the EU special H2020 program “Advancing knowledge for the clinical and public health response to the 2019-nCoV epidemic (call ID: SC1-PHE-CORONAVIRUS-2020) under the grant no. 101003595.
Information and views set out across this project are those of the Consortium and do not necessarily reflect the official opinion or position of the European Union. Neither European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use that may be made of the information contained herein.