HLS Therapeutics reports positive data from Covid-19 outpatient trial

15th December 2020 (Last Updated December 15th, 2020 17:49)

HLS Therapeutics has announced that clinical results from the CardioLink-9 Trial showed Vascepa (icosapent ethyl) provided an anti-inflammatory effect in symptomatic Covid-19 infected outpatients.

HLS Therapeutics reports positive data from Covid-19 outpatient trial
The randomised, open-label trial enrolled 100 Covid-19 outpatients. Credit: Steve Buissinne from Pixabay.

HLS Therapeutics has announced that clinical results from the CardioLink-9 Trial showed Vascepa (icosapent ethyl) provided an anti-inflammatory effect in symptomatic Covid-19 infected outpatients.

The investigator-initiated study was carried out by the Canadian Medical and Surgical Knowledge Translation Research Group, supported by Amarin Pharmaceuticals and HLS.

University of Toronto professor and cardiac surgeon Subodh Verma and Brigham and Harvard Medical School Women’s Hospital Medicine professor Deepak Bhatt are the principal investigators of the study.

The randomised, open-label trial enrolled 100 Covid-19 outpatients with at least one of the symptoms that include fever, cough, sore throat, shortness of breath or myalgia.

In the trial, participants in the Vascepa arm were given a loading dose of 8g/day for three days followed by 4g/day for 11 days along with usual care.

Those in the non-active arm were given usual care.

Data showed that in the treatment group, a 25% reduction in high-sensitivity C-reactive protein (hsCRP) was noted, meeting the primary endpoint.

In addition, Vascepa treatment resulted in a significant 52% reduction of the total patient-reported symptom outcome prevalence score (FLU-PRO) versus 24% reduction in the usual care arm.

This first in-human trial with an 8g/day loading dose of Vascepa demonstrated short-term safety and tolerability in modest sample size, HLS noted.

Verma said: “The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated, and relatively inexpensive option to impact upon Covid-19-related morbidity.

“The reduction in markers of inflammation with icosapent ethyl is also important given what we know about the pathobiology of Covid-19.”

Larger follow-on clinical studies, PREPARE-IT sponsored by Estudios Clínicos Latino América and MITIGATE trial sponsored by Kaiser Permanente, analysing Vascepa as a therapeutic option in Covid-19 settings are progressing.