The US Food and Drug Administration (FDA) has granted approval to Laurent Pharmaceuticals for expanding enrolment in the Phase II RESOLUTION clinical trial with oral antiviral LAU-7b in hospitalised adult subjects with moderate-to-severe Covid-19.
LAU-7b is a new oral formulation of fenretinide, a retinoid that acts on host cells membrane lipids associated with the inflammatory response and replication of the virus.
With the FDA approval, the company will also modify the primary goal of the trial to ‘proportion of subjects requiring mechanical ventilation and/or mortality by day 60’.
The FDA also approved Laurent’s Type B meeting request to hold talks on the eligibility to seek Emergency Use Authorization (EUA) and Phase III clinical trials of the antiviral in hospitalised as well as at-home settings for Covid-19.
The meeting is slated to be held online in January 2022.
According to data from the RESOLUTION trial’s pilot segment, LAU-7b in combination with standard of care (SOC) demonstrated a robust efficacy signal in the subgroup of moderate-to-severe Covid-19 patients admitted to the hospital.
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Furthermore, the oral antiviral offered a complete decline in the risk of progression to mechanical ventilation and mortality by day 60 versus placebo plus SOC.
Five cases of disease progression requiring ventilatory support and four deaths were reported in subjects who received placebo.
LAU-7b demonstrated to be well-tolerated with its safety profile in line with already reported data.
Laurent Pharmaceuticals president and CEO Radu Pislariu said: “Due to its dual antiviral and inflammation-controlling properties, LAU-7b has the potential to be useful in the early viral response phase of the disease, as well as in patients with symptoms of lung inflammation, to help reduce the necessity for mechanical ventilation and overall mortality.
“Moreover, it’s convenient once-a-day oral administration allows for flexible use during hospitalisation, as well as an at-home treatment after discharge.”
This October, the company reported that LAU-7b failed to meet the primary endpoint in the Phase II RESOLUTION trial in Covid-19 patients admitted to the hospital.