Clinical data from patients hospitalised with Covid-19 have shown that 20% of them are suffering from acute respiratory failure (Acute Respiratory Distress Syndrome, ARDS), which is frequently characterised by pulmonary oedema. At present, there are no pharmaceutical agents specifically approved for treating pulmonary permeability oedema or ARDS.
The new active agent solnatide, a synthetic peptide developed by the Viennese company Apeptico, is already being tested on Covid-19 patients at MedUni Vienna.
Markus Zeitlinger, Head of MedUni Vienna's Department of Clinical Pharmacology and Principal Investigator, explains the process: "The drug has already successfully passed clinical trials for treating respiratory failure and is on the verge of being approved. We are now testing it on a cohort of 40 volunteers with Covid-19, half of whom will receive the drug while the other half will form a placebo control group. We are hoping that the new agent will limit the progression of lung disease triggered by the coronavirus. The study has been fast-tracked through the approval process in close consultation with MedUni Vienna's Ethics Committee and the relevant authorities and will be conducted at the Department of Clinical Pharmacology and the Department of Anaesthesia, Intensive Care Medicine and Pain Medicine. Klaus Markstaller, Head of the Department of Anaesthesia, Intensive Care Medicine and Pain Medicine: "We are particularly pleased that the years of preparatory work in this area may offer a therapy option for severe courses of Covid-19".
The active agent solnatide, developed by the Viennese company Apeptico GmbH is a synthetic peptide with less than 20 amino acids.
Based on the clinical studies conducted so far, it is expected that administration of solnatide directly into the lower respiratory tract, in the form of a liquid aerosol, will activate the pulmonary sodium ion channel (ENaC) to directly activate alveolar liquid clearance and to reduce the leakage of blood and fluids from the capillaries. This should reduce the level of alveolar oedema and/or accelerate its resolution. As well as this effect, solnatide counteracts additional complications that are frequently observed in respiratory failure.
The active agent was originally developed for treating patients with acute respiratory failure and various forms of life-threatening pulmonary permeability oedema (PPO). Orally inhaled solnatide had already passed a Phase I clinical trial in humans and a clinical proof-of-concept in a randomised, placebo-controlled, double-blind study (Phase II clinical trial) and also a Phase II pilot study in patients with pneumonia, sepsis, ARDS, primary graft dysfunction or other causes of life-threatening respiratory failure.
"Should the drug prove successful, we are counting on the regulatory authority to fast-track it through the approval procedure," explains Zeitlinger.
The study is funded as part of an FFG Corona Emergency Call.