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

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.