15 February 2022 - - US-based Luminis Health Research Institute in Annapolis MD 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, Canada-based clinical-stage pharmaceutical company Laurent Pharmaceuticals Inc said.

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.

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.

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.

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.

Laurent Pharmaceuticals is a clinical stage biotechnology 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.