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Canada-based Laurent Pharmaceuticals has obtained approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical trial of LAU-7b to treat Covid-19.
LAU-7b is an oral formulation of fenretinide. The drug is expected to induce the resolution phase of inflammation, which is known to control the body’s inflammatory response without stimulating immune-suppression.
In-vitro, the drug demonstrated antiviral activity against SARS-CoV-2 and MERS-CoV coronaviruses.
The randomised, placebo-controlled Phase II trial, called RESOLUTION, is designed to assess a once-daily oral dose of LAU-7b compared to placebo in a total of around 200 hospitalised patients with Covid-19.
Laurent is in advanced talks with multiple US hospitals interested to join the Covid-19 trial and plans to activate them soon.
RESOLUTION is based on the recommendations of the World Health Organization (WHO) Master Protocol for Covid-19 trials.
The Phase II trial will measure the patient health status on a seven-point ordinal scale to assess the disease progression for the primary and secondary endpoints. It will also track the duration of hospitalisation and improvement in quality of life.
Laurent Pharmaceuticals president and CEO Dr Radu Pislariu said: “The main objective of the RESOLUTION study is to demonstrate that LAU-7b is a safe and effective treatment option for Covid-19 patients that are at risk of lung complications because of their age, underlying condition or both.
“We hope that treatment with LAU-7b will slow down the disease progression, prevent the respiratory failure requiring mechanical ventilation, and ultimately reduce the number of fatalities due to the Covid-19.”
The company is also evaluating LAU-7b in a Phase II trial in cystic fibrosis (CF) patients. The drug is expected to address the exaggerated inflammatory response that causes irreversible lung damage in this patient population.