Biophytis (NASDAQ:BPTS)

According to Biophytis (NASDAQ:BPTS), Sarconeos works better than a placebo at lowering the risk of respiratory failure or early mortality in COVID-19 patients.

Sarconeos (BIO101) was compared to a placebo in the phase 2-3 COVA research to treat COVID-19 hospitalized patients with hypoxemia (low oxygen levels) who were at risk of respiratory failure necessitating high flow oxygen or mechanical ventilation as well as mortality.

According to a press release from the firm on September 7, the 233 treated patients, who were on average 63 years old and 64% male, were recruited between the third quarter of 2020 and the first quarter of 2022 in the United States, Europe, and Brazil. 

Results

Compared to placebo (15.8% vs. 26.0%, adjusted difference of 11.8% in favor of treatment), Sarconeos decreased the risk of respiratory failure or early mortality at 28 days by 39% in the primary analysis. 

Sarconeos (BIO101) reports that it decreased the percentage of patients who experienced respiratory failure (12.7% vs. 21.5%) and early mortality (0.8% vs. 2.8%).

Biophytis said that over the course of the maximum 28-day treatment period, the medicine also considerably slowed the progression of respiratory failure or early death. The company pointed out that Sarconeos lowered the risk of mortality at 28 days compared to placebo, in a similar manner to the reported reduction in the risk of respiratory failure or early death, and delayed its occurrence within 90 days, but these benefits were not statistically significant.

When compared to placebo, Sarconeos (BIO101) had a similar percentage of adverse events, particularly severe adverse events (25% vs. 31%). According to the manufacturer, compared to 22.7% of patients taking Sarconeos, 32.7% of patients in the placebo group had respiratory adverse effects.

Biophytis CEO Stanislas Veillet stated, “We will be sharing these results with regulatory agencies, health authorities, and our partners in Europe, the United States, and Brazil in the coming months to determine under what circumstances we can pursue the development of Sarconeos (BIO101) in COVID-19.”

Biophytis is now considering whether to modify and maintain the Early Access Program so that some COVID-19 patients will have access to Sarconeos by the winter.

BPTS rose +45.74% to $1.37 premarket on Sept. 7

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