Brensocatib, an oral investigational therapy being developed to treat bronchiectasis, will be tested in people with a severe COVID-19 infection in an upcoming clinical trial, Insmed, its developer, announced.
The trial, named STOP-COVID19 (Superiority Trial of Protease inhibition in COVID-19), is set to begin enrollment in May. It will take place at 10 centers in the U.K., and is expected to enroll up to 300 people hospitalized with COVID-19 and at risk of needing increased levels of supplemental oxygen and/or ventilation.
The anticipated number of participants will be re-assessed once 100 patients are enrolled.
Those enrolled will randomly receive either bensocatib at 25 mg or a placebo, in addition to standard care, every day for 28 days. The trial’s main goal will be to assess clinical improvement on a seven-point scale defined by the World Health Organization (WHO).
The University of Dundee-sponsored trial has been designated an Urgent Public Health trial by the U.K.’s National Institute for Health Research. The total number of patients necessary for the trial will be re-assessed once the first 100 are enrolled.
Insmed, which acquired rights to brensocatib in 2016, will provide funding and supplies of the treatment for the trial.
Neutrophils are believed to play central roles in inflammatory lung diseases, including bronchiectasis. The accumulation of these cells in the lungs is characteristic of acute respiratory distress syndrome (ARDS), a severe outcome of COVID-19.
Brensocatib was recently evaluated in the Phase 2 WILLOW clinical trial (NCT03218917), which tested its safety and efficacy in adults with non-cystic fibrosis bronchiectasis. In this Insmed-sponsored study, 256 people were given brensocatib, as a daily 10 mg or 25 mg tablet, or a placebo, for 24 weeks.
Results showed that both brensocatib doses significantly delayed the time to first pulmonary exacerbation. The treatment also significantly reduced the frequency of pulmonary exacerbations: by 36% with the 10 mg dose, and by 25% in the 25 mg group.
Brensocatib use in this study was generally well-tolerated. Rates of discontinuation due to adverse events were 7.4% with the 10 mg tablet, 6.7% with 25 mg, and 10.6% with the placebo. The most common adverse events associated with brensocatib were cough, headache, increased sputum production, shortness of breath, fatigue, and upper respiratory tract infection.
Adverse events deemed of special interest were more commonly infections, seen in 16.0% of patients on the lower brensocatib dose, 16.9% in those on 25 mg, and 18.8% of participants taking a placebo.
“The mechanism of action of brensocatib that we observed in a Phase 2 study in patients with non-cystic fibrosis bronchiectasis provides a strong rationale for evaluating this novel treatment candidate in other neutrophil-driven inflammatory conditions,” James Chalmers, PhD, a University of Dundee professor who will lead the STOP-COVID19 trial, said in a press release.
“It is my hope that this novel approach will have applicability in patients at risk of ARDS — a devastating outcome of COVID-19 for which there are currently no approved therapies,” Chalmers added.
Said Martina Flammer, MD, chief medical officer at Insmed: “At the start of the outbreak, Insmed began pursuing an in vivo mouse model to better understand the potential of brensocatib in preventing ARDS … we are very pleased to support Professor James Chalmers and the University of Dundee in leading a controlled clinical trial that will help us evaluate the potential impact of brensocatib on hospitalized patients suffering from severe COVID-19.
“The global COVID-19 pandemic has generated an extraordinary response from the biopharmaceutical industry to bring to bear all potential means of fighting this disease and preventing its most severe outcomes,” she added.
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