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).
LAU-7b is a next-generation COVID-19 oral antiviral that works by stopping the virus access to host cell membrane lipids needed for its entry and replication, a mechanism common to all lipid-enveloped viruses. Because it acts on the host rather than the virus, and also has inflammation-controlling properties, LAU-7b has broad applicability from early infection to severe disease, at-home or in hospital.
“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. There is still an important treatment gap for moderate-to-severe COVID-19 patients, the population most at-risk of progressing to respiratory failure,” said Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals.
Jean-Marie Houle, VP Clinical Development, commented: “We are delighted to see our Phase 3 pivotal trial underway with clinical sites being swiftly activated in the USA and Canada. Existing COVID-19 oral antivirals typically target the virus’s biological machinery, which can be eluded by mutations, and are effective only if taken within 5 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.”
“We now have multiple treatment options for early stage COVID-19, to prevent hospitalization, and a number of drugs to suppress hyperinflammation when a patient reaches critical stage, but not much specifically addressing hospitalized patients with moderate-to-severe COVID-19 to prevent their progression to invasive ventilatory support,” said Dr Barry Meisenberg, MD, a clinical investigator in the RESOLUTION trial. “Preventing ICU overload in this common subset of hospitalized patients is at core of our fight every time we face a new COVID-19 wave, as we try not only to protect the patients from life-threatening complications but also the healthcare system from a new crisis,” added Dr Meisenberg, who is also the chair of the Department of Medicine and medical director of the Research Institute at Luminis Health (formerly Anne Arundel Medical Center) in Annapolis MD, USA.
About LAU-7b
LAU-7b is developed as a broadly effective oral COVID-19 therapeutic targeting host cells membrane lipids to exert dual antiviral and inflammation-controlling activity. SARS-CoV-2 must reprogram host cellular lipid metabolism to favor its entry and replication, a mechanism shared by all lipid-enveloped viruses. Fenretinide, the active ingredient in LAU-7b, works by decreasing host cell membrane lipids fluidity and inhibiting de-novo cell lipogenesis. Because it acts on the host rather than the virus, LAU-7b has potential for broad-spectrum antiviral activity regardless of mutations, as already demonstrated in vitro on multiple SARS-CoV-2 variants (including Delta and Gamma) and the MERS-CoV. Fenretinide was also shown to trigger certain membrane phospholipids metabolic pathways involved in the resolution phase of inflammation, a natural mechanism that keeps the inflammatory response under control without inducing immune-suppression (a “pro-resolving” effect).
About RESOLUTION Phase 2/3 clinical trial
RESOLUTION is a placebo-controlled Phase 2/3 study of oral LAU-7b, administered once-a-day for 14 days on top of standard of care, in hospitalized COVID-19 patients at risk of developing pulmonary complications. Results from RESOLUTION Phase 2 pilot portion showed 100% reduction in the risk of progression to mechanical ventilation and death in LAU-7b-treated hospitalized moderate-to-severe COVID-19 patients, relative to placebo. None of the 76 patients on LAU-7b required mechanical ventilation and none died, while 5 out of 72 patients on placebo progressed to mechanical ventilation (6.9% difference, p=0.025), and 4 patients died (5.6% difference, p=0.053). LAU-7b group also showed an increase of 6.9% (p=0.055) in the proportion of patients alive and free of respiratory failure at Day 29, versus placebo. Both study arms were highly comparable in terms of mean age, number of comorbidities and concomitant medications. Patients on LAU-7b tended to recover more rapidly and leave hospital faster. LAU-7b was well-tolerated, with safety comparable to placebo. Following the positive results in the Phase 2 pilot study, the confirmatory Phase 3 portion was triggered, focusing on moderate-to-severe COVID-19 and using the “Proportion of patients requiring mechanical ventilation and/or death by Day 60” as the primary efficacy endpoint. More details about the RESOLUTION study can be found on www.clinicaltrials.gov, using Identifier NCT04417257.
About Laurent Pharmaceuticals
Laurent Pharmaceuticals is a clinical stage biotech company focusing on the modulation of cell membrane lipids for addressing life-threatening diseases. The company’s lead drug candidate, LAU-7b, is a proprietary oral formulation of fenretinide, an atypical retinoid with a well-documented safety profile established in more than 3,000 patients. Existing data suggest that low-dose fenretinide has the potential to modulate certain membrane lipids and exerts antiviral, inflammatory-controlling, and antifibrotic properties. LAU-7b is currently being evaluated as a potential therapeutic for COVID-19 and Cystic Fibrosis. For more information, please visit www.laurentpharma.com.
