Researchers at The University of Dundee in Scotland, UK are set to lead a clinical trial of Insmed’s brensocatib (formerly INS1007) for the treatment of Covid-19 patients.
Insmed will provide funding and supply the drug, which is being developed to treat lung inflammation in bronchiectasis and other inflammatory conditions.
The new trial, called STOP-COVID19, will assess the drug’s ability to decrease the incidence of acute lung injury and prevent mechanical ventilation in up to 300 hospitalised patients at ten sites across the UK.
Brensocatib is an oral, reversible inhibitor of the dipeptidyl peptidase 1 (DPP1) enzyme, which catalyses the neutrophil serine proteases (NSPs) activation in neutrophils when formed in the bone marrow.
Neutrophils are known to be associated with in pathogen destruction and inflammatory mediation. Inhibition of the NSPs activation is expected to help treat various neutrophil-mediated diseases.
Meanwhile, acute respiratory distress syndrome (ARDS), which is a severe Covid-19 complication, is characterised by neutrophil influx into the lungs.
It is expected that by decreasing neutrophil proteases, the progression of lung injury and the need for ventilation related to Covid-19 can be decreased.
University of Dundee respiratory research professor James Chalmers said: “The mechanism of action of brensocatib observed in a study in bronchiectasis patients provides a strong rationale for evaluating this novel treatment candidate in other neutrophil-driven inflammatory conditions.
“It is my hope that it will have applicability in patients at risk of ARDS, a devastating outcome of Covid-19 for which there are currently no approved therapies.”
In the prospective, randomised, double-blind, placebo-controlled STOP-COVID19 trial, participants will be given once-daily, 25mg brensocatib or placebo, along with standard of care.
The primary endpoint is clinical improvement on a seven-point ordinal scale defined by the World Health Organization. Patients will receive treatment for 28 days and a sample-size reassessment will be conducted after the enrolment and treatment of 100 patients.
Insmed will continue to study brensocatib for bronchiectasis and plans to start enrolling for a Phase III programme in the second half of this year.