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September 16, 2021

Biophytis to continue Phase II/III Covid-19 drug trial without changes

According to interim analysis 2, the trial was in a promising zone and does not need modifications in sample size.

Biophytis has reported that the Data Monitoring Committee (DMC) recommended the continuation of the Phase II/III COVA clinical trial of its oral antiviral, Sarconeos (BIO101), without any protocol amendments.

The development follows promising interim efficacy data in the second interim analysis (IA2), based on 155 hospitalised Covid-19 patients with respiratory failure.

Biophytis noted that the latest advice concludes an earlier safety assessment conducted by DMC in August 2020 that established the good safety profile of Sarconeos.

The international, multicentre, double-blind, placebo-controlled, group-sequential and adaptive design two-part Phase II/III trial assessed Sarconeos in subjects aged 45 years or above.

The Phase II exploratory proof of concept trial offered initial data on the safety and tolerability and efficacy of the drug in 50 subjects.

Meanwhile, the Phase III pivotal randomised trial is assessing the safety and efficacy of Sarconeos on the respiratory function in 310 to 465 subjects, including those who were part of the Phase II trial.

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The trial’s primary goal is the proportion of subjects with ‘negative events’ of either all-cause mortality or respiratory failure defined as needing mechanical ventilation or extracorporeal membrane oxygenation.

According to the findings of IA2, the trial is currently showing a promising trend and hence the sample size will not be modified according to the existing protocol.

This trend signifies that Sarconeos is still a therapy candidate for acute respiratory failure associated with Covid-19.

The trial is not in the unfavourable zone, which would have led to a halt due to futility but has not yet demonstrated statistically significant efficacy.

Biophytis CEO Stanislas Veillet said: “The DMC recommendation suggests that the trial is well on track to lead to conclusive efficacy results at the final analysis.

“We hope that Sarconeos (BIO101) will become one of the first drug candidates able to restore breathing capabilities of hospitalised patients in severe conditions, and therefore avoiding their admission to ICUs.”

So far, 200 subjects were enrolled in the trial with 35 trial sites opened to recruit patients in the US, Brazil, France and Belgium.

The company plans to launch 15 additional centres in the US, Brazil, UK, France and Belgium to expedite participant recruitment and report top-line data in the first quarter of next year.

Biophytis will submit the latest data to all drug regulators to progress the subject recruitment and intends to make Sarconeos ready for marketing in the first half of next year.

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