Frequently Asked Questions

Solnatide IMP (Investigative Medicinal Product) is a therapeutic peptide. It is a synthetic molecule whose structure is based on the lectin-like domain of human Tumour Necrosis Factor alpha. It is water soluble and can be administered as aerosol directly into the lung of patients by oral inhalation.

Solnatide IMP has been designed for activation of the pulmonary epithelial sodium channel (ENaC) and for the restoration of the injured endothelial-epithelia barrier of pulmonary alveoli.

Currently, it is tested within the SOLNATIDE project, an EU-funded H2020 Emergency Call project, set out to test the peptide’s safety, tolerability and clinical efficacy. In parallel it is available for Compassionate Use Programs in Austria and Italy.

The SOLNATIDE project is funded by 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). At the beginning of the global COVID-19 pandemic end of January 2020, the EU immediately opened a call to tackle several aspects of the COVID-19 infection and pandemic.

The SOLNATIDE project (grant no. 101003595) was one of the first 18 projects funded under this EU Emergency Call. It is set out to test the safety, tolerability and clinical efficacy of solnatide IMP.

Five organisations from four European countries (Austria, Germany, Italy and Spain) are the partners of the SOLNATIDE consortium:

RTDS – the Project Coordinator (Austria)

APEPTICO – the Scientific Coordinator and Clinical Study Sponsor (Austria)

BCN Peptides (Spain)

LMU (Germany)

OPIS (Italian and German company branches)

To read more about each partner and their respective roles and responsibilities within the SOLNATIDE project visit our partner page.

APEPTICO Forschung und Entwicklung GmbH is an Austrian biotechnology company with headquarters in Vienna developing peptide-based products for chronic and life-threatening diseases.

To learn more about their roles and responsibilities within the SOLNATIDE project visit our partner page.

The RTDS Group is the Project Coordinator of the SOLNATIDE project and also responsible for project communication.  RTDS is an EU funding consultancy and service company based in Vienna.

To learn more about their roles and responsibilities within the SOLNATIDE project visit our partner page.

The SOLNATIDE project will run for about 2 years. It started on April 1st 2020 and will be completed by 31st December 2021.

Patients infected with the new Coronavirus (SARS-CoV-2, 2019-nCoV) may suffer from COVID-19 (Corona Virus Disease 2019) which further progresses to severe respiratory failure and presence of Pulmonary Permeability Oedema (PPO).

About a third of these patients further develop life-threatening Acute Respiratory Distress Syndrome (ARDS) resulting in a very high mortality rate.

To date (as of October 2020), worldwide no medicine has been approved for the therapeutic treatment of COVID-19, Pulmonary Permeability Oedema and ARDS.

To get a quick overview of the projects’ set-up have a look at our communication materials (factsheet, project presentation).

The investigational compound solnatide (INN) has been designed for the therapeutic treatment of Acute Respiratory Distress Syndrome (ARDS) and various forms of Pulmonary Permeability Oedema (PPO).

Clinically, it can be given to severe COVID-19 patients via oral inhalation treatment by trained hospital staff of Intensive Care Unit (ICU).

To get a quick overview of the projects’ set-up have a look at our communication materials (factsheet, project presentation).

As of October 2020, the main drug component, APEPTICO’s lead-compound solnatide IMP, has delivered clinical proof-of-concept in one Phase I and two Phase II clinical studies (EUDRACT No. 2011-000223-33, 2012-001863-64 and 2013-000716-21) when being orally inhaled to patients with ARDS and PPO.

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.

In addition, solnatide has been approved for Compassionate Use for treatment of severe COVID-19 in various EU member states, including Austria and Italy.

Patients suffering severely from COVID-19 are very prone to various lung diseases such as severe respiratory failure, Pulmonary Permeability Oedema (PPO), Acute Respiratory Distress Syndrome (ARDS), some of which result in very high mortality rates.

Yes! In addition to the treatment of severely ill COVID-19 patients within the Phase IIB clinical study, solnatide has been applied to COVID-19 patients within the Compassionate Use Program in Austria and Italy. This includes a patient who received a lung transplantation following COVID-19 treatment. The case was published in Sept. 2020 in “The Lancet” journal.

Three clinical studies have already shown proof-of-concept of the solnatide compound. They demonstrated it was safe for and generally well tolerated by patients.

Oral inhalation of solnatide in mechanically ventilated patients suffering from PPO and ARDS led to these 8 distinct improvements  and benefits:

  • Earlier alveolar liquid clearance in the patients’ lungs
  • Reduction of pressure in ventilator settings
  • Reduction of positive end-expiratory ventilator pressure
  • Reduction of oxygenation index
  • Reduction of Murray lung injury score
  • Improvements of ventilator-free days
  • Earlier extubation
  • Shorter stay and treatment at ICU

The solnatide drug is not available to the general public since it was designed to be administered by physicians in Intensive Care Units (ICU) of hospitals.

Patients infected with the SARS-CoV-2 and developing severe COVID-19, have increasingly low levels of oxygen and often need to be intubated and mechanically ventilated. To alleviate their illness, the doctors can give solnatide to their hospitalised patients at ICU.

 If you are a physician or representing a hospital or a research organisation you are very welcome to contact the Scientific Coordinator and study sponsor Bernhard Fischer (APEPTICO) at b.fischer (at) apeptico.com on more information on the Compassionate Use Program for solnatide. Solnatide IMP is made available for free during the program.  

Currently, solnatide is subject to a phase IIB clinical study at nine medical facilities: The medical universities in Vienna, Innsbruck, Graz (all Austria), as well as in Munich, Aachen, Würzburg, Kiel, Bonn and Mainz (all Germany).

Due to the Compassionate Use Program, solnatide can now also be requested by other hospitals for treatment of severe COVID-19 patient for free.

If you are a physician, representing a hospital or a research organisation you are very welcome to contact the Scientific Coordinator and study sponsor Bernhard Fischer (APEPTICO) at b.fischer (at)apeptico.com for more information on the Compassionate Use Program for solnatide.

Go to the news & media section to find our latest announcements on the solnatide drug development and the SOLNATIDE project.

Have a look at our presentation and read the factsheet on the communication materials page or go to the EU CORDIS database to learn more about SOLNATIDE.

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We sure hope to have provided you with answers to the most pressing questions on this FAQ site. If you have more questions contact the scientific coordinator APEPTICO or the project coordinator RTDS at solnatide (at) rtds-group.com.

We would also love you to stay in touch with us through our SOLNATIDE social media channels: