MONTREAL--(BUSINESS WIRE)--Laurent Pharmaceuticals Inc., a Montreal-based biopharmaceutical company, today announced that it has obtained the approval from Health Canada to initiate ESSOR, an adaptive Phase 2/3 randomized placebo-controlled trial testing its oral drug candidate LAU-7b as a potential treatment for Long COVID. The Phase 2 portion, which will involve 204 adult patients with moderate to severe Long COVID, is conducted with financial support from the Government of Canada via the National Research Council of Canada (NRC) Industrial Research Assistance Program (IRAP).
MONTREAL--(BUSINESS WIRE)--Laurent Pharmaceuticals Inc. (the “Company”), a clinical-stage biopharmaceutical company developing LAU-7b (oral fenretinide) as a first-in-class inflammation-controlling drug candidate for Cystic Fibrosis (CF), announces the presentation of results from its placebo-controlled Phase 2 APPLAUD 24-week clinical study in adults with CF at the North American Cystic Fibrosis Conference (NACFC) currently held in Philadelphia, United States.
MONTREAL--(BUSINESS WIRE)--Laurent Pharmaceuticals Inc. (the “Company”), a clinical-stage pharmaceutical company, today announced that Luminis Health Research Institute in Annapolis MD, USA, has dosed the first patient in the Phase 3 expansion of the RESOLUTION Phase 2/3 clinical trial evaluating the efficacy of the novel COVID-19 oral antiviral LAU-7b in hospitalized moderate-to-severe patients at high risk of developing lung complications. This Phase 3 confirmatory study was triggered following a successful meeting with the FDA, which also provided recommendations on the regulatory path to Emergency Use Authorization (EUA).
MONTREAL--(BUSINESS WIRE)--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.
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.
MONTREAL--(BUSINESS WIRE)--Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing LAU-7b, a first-in-class pro-resolving drug candidate, reported today topline results from its Phase 2 RESOLUTION clinical trial in hospitalized COVID-19 patients. This 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. The trial randomized 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.
Another small biotech trying to make a play in COVID-19 treatment has hit a brick wall in clinic trials. This time it’s Laurent Pharmaceuticals, which reported that an oral candidate for hospitalized patients was unsuccessful in a mid-stage trial.
MONTREAL--(BUSINESS WIRE)--Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing the first-in-class pro-resolving drug LAU-7b, today announces that it has completed the enrollment for its placebo-controlled Phase 2 RESOLUTION clinical study of hospitalized patients with COVID-19. The study, which enrolled 240 patients across Canada and United States, is expected to report top-line results in Q3 2021.
Laurent Pharmaceuticals has decided to continue the study of its pro-resolving drug LAU-7b without modification in the Phase II RESOLUTION study in hospitalised Covid-19 patients.
Laurent Pharmaceuticals has decided to continue the study of its pro-resolving drug LAU-7b without modification in the Phase II RESOLUTION study in hospitalised Covid-19 patients.