Trial Begins for Advanced Covid-19 Disease Anti-Viral

(Heung Soon, Pixabay. https://pixabay.com/photos/approximately-health-3887433/)

15 Feb. 2022. A late-stage clinical trial is underway testing an oral anti-viral drug to treat moderate to severe cases of Covid-19 infections. The drug, code-named LAU-7b, is made by Laurent Pharmaceuticals Inc. in Montreal, Quebec, Canada with a patient enrolled in the trial receiving the first dose of the drug or placebo.

Laurent Pharma develops treatments addressing lipids, or natural oils, making up the structure and functions of cell membranes. Those lipids, says the company, play key roles in cell defenses against pathogens and signaling presence of inflammation. Laurent Pharma says its technology targets lipids with various acidic compositions linked to pathogen defense, or the activation or resolution of inflammation.

To treat Covid-19 infections, says Laurent Pharma, LAU-7b uses a low-dose formulation of the cancer drug fenretinide that reduces fluidity and limits production of new lipids on cell membranes. As a result, invading SARS-CoV-2 viruses, enveloped with lipids, cannot restructure cell membrane lipids to enable their penetration and infection of host cells. And, says the company, since LAU-7b acts on host cells and not proteins in the SARS-CoV-2 virus, the drug can treat infections from a range of SARS-CoV-2 variants. Laurent Pharma says lab tests show LAU-7b stops SARS-CoV-2 gamma and delta variants, as well as the earlier Middle East Respiratory Syndrome or MERS-CoV coronavirus.

Hospitalized patients with moderate to severe Covid-19

“Existing Covid-19 oral antivirals typically target the virus’s biological machinery,” says Laurent Pharma vice-president Jean-Marie Houle in a company statement, “which can be eluded by mutations, and are effective only if taken within five days of symptoms onset, during the virus proliferation stage. LAU-7b has the potential to become the next generation pan-coronavirus oral pill, so we will never be caught off-guard again by this virus.”

The clinical trial is a combination mid- and late-stage study eventually recruiting 508 participants at 14 sites in the U.S. and Canada. Participants are hospitalized patients with moderate to severe cases of Covid-19 infections, randomly assigned to receive a daily LAU-7b or placebo capsule for 14 days. At that point participants are tracked for 60 days, looking primarily for changes on a seven-point disease status scale, from non-hospitalized with no limitations to deceased. The study team is particularly tracking rates for the two most severe outcomes: hospitalized with mechanical ventilation needed or death.

The mid-stage or phase 2 part of the study enrolled 148 participants, with none of the 76 LAU-7b recipients dying or requiring mechanical ventilation, while nine of the 72 placebo recipients required mechanical ventilation or died. By day 29, says the company, more LAU-7b than placebo recipients were alive and free of respiratory failure, with LAU-7b recipients also more likely to recover faster and leave the hospital earlier. The mid-stage findings allowed for the late-stage part of the trial to begin, with the first participant at Lumis Health in Annapolis, Maryland receiving an initial dose.

Laurent Pharma says it met with the U.S. Food and Drug Administration that cleared the company to begin the late-stage part of the trial. “We are excited to reach the Phase 3 development milestone and the positive feedback received from the FDA, confirming the progress made so far with our LAU-7b program in Covid-19.” notes company president and CEO Radu Pislariu. “There is still an important treatment gap for moderate-to-severe Covid-19 patients, the population most at-risk of progressing to respiratory failure.”

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