Laurent Pharmaceuticals has reported that its pro-resolving drug candidate, LAU-7b, failed to meet the primary goal of the Phase II RESOLUTION clinical trial in hospitalised Covid-19 patients.
LAU-7b is a new oral form of fenretinide, an atypical retinoid that acts on certain cell membrane lipids linked to viral replication and immune-inflammatory responses.
The double-blind, placebo-controlled Phase II trial assessed the efficacy and safety of a once-daily oral dose of LAU-7b administered for 14 days, along with the standard of care (SOC).
It enrolled a total of 232 hospitalised patients with moderate, severe or critical Covid-19 disease.
Of these, 148 subjects had moderate-to-severe disease who did not need oxygen or low-flow oxygenation and 84 patients were critically ill needing high-flow oxygen but not mechanical ventilation.
According to data from the overall moderate-to-critical patient population, the trial failed to meet its primary goal of improving the proportion of subjects alive and free of respiratory failure on day 29.
A clinically meaningful efficacy signal was attained in the pre-specified subgroup of moderate-to-severe Covid-19 patients.
In addition, LAU-7b plus SOC offered a complete decline in the risk of all-cause mortality and the risk of progression to mechanical ventilation by day 60 versus placebo.
In the moderate-to-severe Covid-19 patients, the trial demonstrated a 6.9% relative rise against placebo in the proportion of patients alive and free of respiratory failure at day 29 in those receiving LAU-7b.
Furthermore, LAU-7b demonstrated to be well-tolerated, with a safety profile in line with the placebo group and consistent with the already known safety data.
The subgroup analysis of critically ill Covid-19 patients did not demonstrate an improvement in the LAU-7b group versus placebo. This indicates that these patients may be too severely affected to benefit from the LAU-7b therapy, Laurent noted.
Laurent Pharmaceuticals president and CEO Radu Pislariu said: “The results from the moderate-to-severe subgroup are very promising, suggestive of a potential clinical benefit of LAU-7b in Covid-19 patients that are not yet in respiratory failure, which also represents the patient population with the fewest treatment options.
“An oral therapeutic that prevents serious Covid-19 illness and death, also allowing patients to continue the treatment at home after discharge from hospital, would be a powerful tool in the therapeutic arsenal against Covid-19.”
Based on the topline data from the trial, Laurent intends to focus its future development on moderate-to-severe Covid-19 patients and the key goals linked to the observed clinical benefit.
The company also plans to seek guidance from various drug regulators on potential future strategies.
In April 2021, Laurent decided to continue the study of LAU-7b without modification in the Phase II RESOLUTION study in hospitalised Covid-19 patients.