Biopharmaceutical company Laurent Pharmaceuticals Inc announced on Thursday topline results from its Phase 2 RESOLUTION clinical trial of LAU-7b, a first-in-class pro-resolving drug candidate, in hospitalized COVID-19 patients.

The double-blind, placebo-controlled trial evaluated the efficacy and safety of once-a-day oral LAU-7b, administered for 14 days on top of standard of care. It included a total of 232 hospitalized patients with moderate, severe or critical COVID-19 disease, of which 148 patients had moderate-to-severe disease (not requiring oxygen or requiring low-flow oxygenation) and 84 were critically ill COVID-19 patients requiring high-flow oxygen but not mechanical ventilation.

In the overall moderate-to-critical patient population, the study did not meet its primary endpoint of improving the proportion of patients alive and free of respiratory failure on Day 29.

A clinically meaningful efficacy signal was achieved in the subgroup of moderate-to-severe COVID-19 patients, with LAU-7b plus standard of care demonstrating a 100% reduction in the risk of all-causes death and the risk of progressing to mechanical ventilation by Day 60, when compared to placebo plus standard of care. None of the 76 moderately to severely ill patients treated with LAU-7b plus standard of care died or progressed to mechanical ventilation, while four patients died and five progressed to mechanical ventilation in the placebo arm. The study also showed an improvement of 6.9% relative to placebo in the proportion of patients alive and free of respiratory failure at Day 29 treated with LAU-7b, in this moderate-to-severe COVID-19 patient population.

The subgroup analysis of critically ill COVID-19 patients did not show an improvement in the LAU-7b arm over placebo, suggesting that patients already in respiratory failure at baseline may be too severely affected by the disease to benefit from the LAU-7b treatment.

Based on these results, the company plans to focus its future development on patients with moderate-to-severe COVID-19 disease and on the key endpoints associated with the observed clinical benefit, and will seek guidance from the regulatory agencies on potential strategies moving forward, which may include amending and extending the RESOLUTION trial.