The SOLNATIDE project was successfully finished in June 2022!
1) Preliminary data from the clinical studies show that the solnatide IMP is safe: there were no drug- related adverse events in COVID-19 patients.
2) Interim clinical data from the clinical studies show a positive trend towards improvements of mortality with the therapeutic use of solnatide.
3) The data support the continued use of solnatide for the therapeutic treatment of patients with moderate-severe COVID-19.
4) The 3D structure of the solnatide peptide has been deduced from NMR experiments to further specify the Mode of Action of solnatide.
Check the scientific publications and two final public deliverables for more details!
https://www.solnatide.eu/news-media/publications/
Feel free to contact project partners for more information:
APEPTICO: developed and owns solnatide IMP, main clinical study sponsor
Department of Anaesthesiology of the University Clinic of the Ludwig-Maximilians-University Munich: running the clinical trial
BCN Peptides: manufactured and characterized solnatide IMP
OPIS: clinical trial management
RTDS Group: coordination and communication
Challenge
Patients infected with the new Coronavirus (severe acute respiratory syndrome Coronavirus; SARS-CoV-2) suffer from severe respiratory failure, and presence of a life-threatening Pulmonary Permeability Oedema (PPO). Approximately 30% of COVID-19 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 severe COVID-19, PPO and ARDS.
Project overview
The SOLNATIDE project will clinically test peptide-based products targeting life-threatening pulmonary diseases (such as oedematous respiratory failure, acute lung injury). APEPTICO’s lead-compound solnatide investigative medicinal product (solnatide IMP) has been designed for the therapeutic treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and various forms of PPO.
Orally inhaled; solnatide has delivered clinical proof-of-concept in one Phase I clinical study and two Phase II clinical studies (EUDRACT No. 2011-000223-33, 2012-001863-64 and 2013-000716-21). Currently, solnatide is subject to a Phase IIB trial (EUDRACT No. 2017-003855-47) with clinical trials approved by the competent authorities and ethics committees in Germany and Austria.
In addition, solnatide has been approved for Compassionate Use for the therapeutic treatment of severe COVID-19 in Austria and in Italy in April 2020, and been taken up as well in the Italian AIFA register.
SOLNATIDE project outputs
The SOLNATIDE project will generate additional clinical trial results related to safety, tolerability and clinical efficacy of solnatide IMP in severe COVID-19 patients with PPO and ARDS. Therefore, the main outputs of SOLNATIDE are:
- Produce interim clinical data
- Receive approval for immediate use of solnatide for treatment of severe COVID-19 patients
- Demonstrate safety, tolerability and clinical efficacy of solnatide in severe COVID-19 patients
The clinical use of solnatide IMP by patients with ARDS / severe COVID-19 should lead to early alveolar liquid clearance (ALC), reduced airway pressures, increased oxygenation and shortened duration of assisted ventilation. This will limit further lung injury and prevent ventilator-associated lung injury as well as improve oxygenation of vital organs. A rapid improvement of lung function will also lead to decreased treatment days at ICU and positively influence (improve) mortality rates.
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