Mereo BioPharma and the University of Alabama at Birmingham (UAB) in the US have reported positive results from the Phase Ib/II COSTA clinical trial of a new oral drug, alvelestat, in hospitalised Covid-19 patients with respiratory disease.
Alvelestat is an active inhibitor of Neutrophil Elastase (NE).
The randomised, placebo-controlled, single-site, double-blind, investigator-led trial assessed the safety and tolerability of alvelestat plus standard of care (SOC) in adult subjects aged 18 years and above with Covid-19 respiratory disease.
Subjects were given alvelestat or placebo twice a day for five days with an option to extend the treatment to ten days as per the investigator’s choice.
The primary goal was safety and tolerability to day 60, with mortality analysis at day 90.
Clinical outcomes to day 60 were the trial’s secondary goals.
Findings showed that alvelestat was safe and well-tolerated in Covid-19-infected individuals.
No safety signals were reported in lab safety monitoring which is in line with the already reported safety profile of the oral drug.
In the trial, four subjects who received alvelestat had treatment-emergent headaches which were more frequent than placebo arm with one case observed.
This event was concluded to be not linked to the trial drug with no difference in frequency of other adverse events between alvelestat and placebo groups noted till day 60.
Alvelestat plus SOC offered a quicker time to improvement in WHO Disease Severity score of >=2 in the initial five to seven days versus placebo plus SOC.
By day five, nearly 62.5% of the subjects in the alvelestat arm exhibited a two-point decline in the WHO Disease Severity score versus 28.5% in the placebo group.
Furthermore, on day seven, the alvelestat arm’s improvement score climbed to 87.5% as against 57% in subjects who received placebo.
UAB Pulmonary, Allergy and Critical Care Medicine associate professor Dr Mike Wells said: “The early results with alvelestat suggest a potential for clinical benefit over and above the standard of care including dexamethasone and remdesivir.
“This is exciting given the ease of administration of a well-tolerated oral therapy in this acutely ill population. These findings provide strong data and set the stage for future studies with relevant clinical end-points.”
In December 2018, Mereo BioPharma announced plans to merge business with OncoMed Pharmaceuticals.