The phase 2-3 study, called COVA, evaluated Sarconeos (BIO101) versus placebo for the treatment of hypoxemic (low oxygen) hospitalized COVID-19 patients at risk of respiratory failure requiring high oxygen supply or mechanical ventilation and death.
The 233 patients treated had an average age of 63, with 64% of patients being male, recruited in the US, Europe and Brazil between Q3 2020 and Q1 2022, the company said in a Sept. 7 press release.
Biophytis noted that in the primary analysis, Sarconeos reduced the risk of respiratory failure or early death at 28 days (the primary endpoint) by 39% compared with placebo (15.8% vs. 26.0%, adjusted difference 11.8% in favor of treatment) .
According to the company, Sarconeos (BIO101) reduced the proportion of patients with respiratory failure (12.7% vs. 21.5%) and early death (0.8% vs. 2.8%).
Biophytis added that the drug also significantly delayed the progression of respiratory failure or early death during the 28-day maximum treatment period.
The company, however, noted that Sarconeos reduced the risk of death after 28 days compared with placebo, in the same proportion as the observed reduction in the risk of respiratory failure or early death and delayed its onset by 90 days, but these effects were not statistically significant. are significant.
Sarconeas (BIO101) showed a good safety profile with a similar proportion of side effects compared to placebo, especially serious side effects (25% vs. 31%).
The company said 32.7% of patients in the placebo group experienced respiratory side effects, compared to 22.7% of patients on Sarconeos.
“In the coming months, we will share these results with regulatory authorities, health authorities and our partners in Europe, the US and Brazil to determine under what conditions we can continue the development of Sarconeos (BIO101) in COVID-19,” he said. CEO of Biophytis, Stanislaus Veillet.
Biophytis added that it is evaluating the possibility of making changes and continuing the early access program to make Sarconeos available before winter for some patients with COVID-19.
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