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.
LAU-7b is a new oral form of fenretinide, an atypical retinoid that works on fatty acid desaturases to regulate key membrane lipids that perform key roles in inflammation and immune defence.
This development comes after the independent Data Safety Monitoring Board (DSMB) recommended continuation of the trial after it conducted a pre-scheduled safety review and mid-study interim futility analysis of unblinded efficacy data from the first 102 patients treated in the trial.
The placebo-controlled study is analysing whether LAU-7b is a safe and effective treatment option for hospitalised Covid-19 patients who are at risk of lung complications owing to age or underlying conditions or both.
It will enrol 220 subjects in hospitals across the US and provide treatment to the participants for 14 days.
To inform the trial’s primary and secondary endpoints, it will evaluate disease progression on a 7-point ordinal scale. Duration of hospitalisation and progress in the quality of life will also be evaluated.
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Laurent Pharmaceuticals president and CEO Radu Pislariu said: “Because fenretinide targets the human host cell membrane lipids involved in both viral replication and immune-inflammatory responses, its activity is expected to be maintained regardless of the coronavirus variants and be complementary to virus-specific antivirals such as remdesivir.
“LAU-7b has a well-established safety profile, a convenient once-a-day oral administration, and potential for a dual antiviral and inflammation-controlling mechanism of action, which bears the promise of a treatment candidate addressing multiple key contributors to the severity of Covid-19.”
The company has also concluded enrolment in its Phase II APPLAUD study of LAU-7b to treat adult patients with Cystic Fibrosis (CF).
This placebo-controlled study is assessing the efficacy and safety of LAU-7b in CF treatment will also analyse LAU-7b’s effect on the resolution of inflammation and preservation of lung function.