MONTREAL– Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has allowed the Phase 2 RESOLUTION study extension in hospitalized moderate-to-severe adult COVID-19 patients and the change of the primary endpoint to “proportion of patients requiring mechanical ventilation and/or death by Day 60.” The company also announced that the FDA has granted a Type B meeting request to discuss, among other topics, the eligibility to Emergency Use Authorization (EUA) and Phase 3 clinical trials with LAU-7b in COVID-19, in both hospitalized and ambulatory settings. The meeting will take place on January 14th, 2022, via conference call.
Results from the pilot portion of the RESOLUTION study, a well-controlled, randomized trial, showed a strong efficacy signal in the subgroup (n=148) of moderate-to-severe hospitalized COVID-19 patients, with LAU-7b plus standard of care demonstrating a 100% reduction in the risk of progressing to mechanical ventilation and death by Day 60, when compared to placebo plus standard of care. More specifically, none of the 76 moderately to severely ill patients treated with LAU-7b plus standard of care progressed to mechanical ventilation or died, while five (5) progressed to mechanical ventilation (5/72, 6.9%, p=0.025), and four (4) patients died (4/72, 5.6%, p=0.053), in the placebo arm. The study drug was administered for 14 days on top of standard of care. LAU-7b was well-tolerated, with a safety profile comparable to the placebo arm and consistent with the existing safety data. In light of these promising findings, the RESOLUTION study protocol was amended to expand the enrollment and confirm the observed clinical benefit in hospitalized adult patients with moderate-to-severe COVID-19 disease.
“There is a real unmet need for broadly effective easy-to-administer oral antiviral treatments that can be used for moderate-to-severe COVID-19 patients, both in the hospital and ambulatory care,” said Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals. “Emerging oral antivirals are limited by a short administration window, within five days of symptoms onset, and thus their effectiveness is highly dependent on patients seeking early care and having rapid access to COVID-19 testing and results. 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 hospitalization, as well as an at-home treatment after discharge,” added Dr Pislariu.
“The development of drugs and treatments like those currently under study is part of the solutions of the future to fight the pandemic,” declared Pierre Fitzgibbon, Québec’s Minister of Economy and Innovation and Minister Responsible for Regional Economic Development. “Our government will continue to support dynamic businesses such as Laurent Pharmaceuticals, which pursue the important mission of improving the quality of life of many citizens in Québec and elsewhere in the world.”
The RESOLUTION Phase 2 program in COVID-19 is supported by the Canada government via the National Research Council of Canada (NRC) Industrial Research Assistance Program (IRAP), as well as by the Québec government via Investissement Québec.
