US-based BioAegis Therapeutics has received approval from the Spanish Agency for Medicines and Health Products (AEMPS) to conduct a Phase II clinical trial of recombinant human plasma gelsolin (rhu-pGSN) in Covid-19 patients.
The trial is meant for hospitalised patients suffering from severe Covid-19 pneumonia.
BioAegis intends to begin enrolment soon and initiate the study at Hospital Universitari Sant Joan de Reus in Tarragona, Spain.
A protein present in healthy people, gelsolin is involved in regulation of inflammation.
Severe injury or infection results in depletion of the body’s gelsolin supply, which can cause an overexuberant inflammatory response, organ damage and death, similar to that seen in Covid-19 patients.
The company expects that repletion of the depleted gelsolin supply with rhu-pGSN could hinder the cytokine storm caused by Covid-19.
BioAegis Therapeutics CEO Susan Levinson said: “Supplementing gelsolin levels has been successful in over 20 animal models. Our recently published study in viral pneumonia revealed direct genetic evidence that this promoted lung tissue repair and down-regulated the release of injurious cytokines.
“After recently completing a highly successful safety study in hospitalized pneumonia patients we are looking forward to improving outcomes in severely ill Covid-19 patients.”
The randomised, double-blind, placebo-controlled, proof-of-concept Phase II trial will assess rhu-pGSN given with standard of care to treat approximately 60 patients with severe Covid-19 pneumonia.
Primary outcome measures are safety, tolerability and efficacy. The trial is expected to be completed in September this year.
BioAegis chief medical officer Dr Mark DiNubile said: “Harnessing the body’s immune system offers an innovative approach that may lead to more effective therapies for Covid-19 and other serious infectious and non-infectious inflammatory diseases.”
Currently, the National Institutes of Health (NIH) Clinical Center is measuring patient gelsolin levels as part of the National Institute of Allergy and Infectious Diseases (NIAID) Covid-19 research.
The research is intended to gain better insights into the immune response during the infection and convalescence phases.