The phase 2-3 study, dubbed COVA, evaluated Sarconeos (BIO101) against placebo, to treat hospitalized patients with COVID-19 with hypoxemia (low oxygen levels), at risk of respiratory failure requiring high flow oxygen or mechanical ventilation, and death.
The 233 treated patients were 63 years old on average, 64% of the patients were male, recruited in the U.S., 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 by 39% the risk of respiratory failure or early death at 28 days (main goal) compared to placebo (15.8% vs 26.0%, adjusted difference 11.8% in favor of treatment).
Sarconeos (BIO101) reduced the proportion of patients with respiratory failure (12.7% vs 21.5%) and early death (0.8% vs 2.8%), according to the company.
Biophytis added that the drug also significantly delayed the progression of respiratory failure or early death over 28 days maximum treatment period.
The company, however, noted that Sarconeos reduced the risk of death at 28 days compared to placebo, in similar proportion to the observed reduction in the risk of respiratory failure or early death and delayed its occurrence within 90 days, but these effects were not statistically significant.
Sarconeos (BIO101) showed a good safety profile, with a similar proportion of adverse events compared to placebo, particularly severe adverse events (25% vs 31%).
The company said that 32.7% of patients in the placebo group experienced respiratory adverse events, compared to 22.7% on Sarconeos.
“We will be sharing these results in the coming months with regulatory agencies, health authorities and our partners in Europe, the United States and Brazil to determine under what conditions we could pursue the development of Sarconeos (BIO101) in COVID-19,” said Biophytis CEO Stanislas Veillet.
Biophytis added that it is evaluating the possibility of amending and continuing the Early Access Program to make Sarconeos available by winter to certain patients with COVID-19.
BPTS +45.74% to $1.37 premarket Sept. 7
Image and article originally from seekingalpha.com. Read the original article here.