BPTS - Biophytis surges 32 % as COVID drug cuts risk of early death in trial

Biophytis ( NASDAQ: BPTS ) said its medicine Sarconeos help cut the risk of early death or respiratory failure in patients with COVID-19 in a post-hoc analysis of a phase 2-3 trial.

The company had reported data from this phase 2-3 study , dubbed COVA, in September and has now released full results.

The trial 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 company noted that the trial had ended early before reaching the 310 patients originally planned, due to stalled recruitment. The 233 treated patients (the Intent-To-Treat - ITT population) were 63 years old on average. The sub-population of patients without major protocol deviations (PP sub-population) included 180 patients with similar demographics and disease as the ITT population.

The post-hoc data showed that Sarconeos reduced the risk of early death or respiratory failure at day 28 by 45% in the ITT population and by 53% in the PP population.

On mortality follow-up over 90 days, Sarconeos cut the the risk of death at day 90 by 43% in the ITT population and 70% in the PP population, the company added.

Biophytis said the analysis strongly strengthens the trend shown in the primary analysis with similar reduction of risk of death at day 28 which was not significant.

The company added that Sarconeos (BIO101) had a good safety profile, with a lower proportion of patients (57%) with adverse events compared to placebo (64%), in particular a lower frequency of serious, mostly respiratory, adverse events (25% vs. 31%).

"We will start sharing these results in the coming months with regulatory agencies and health authorities, particularly in Europe, the US and Brazil. The aim is to file for conditional marketing authorisation (Europe) and emergency use authorization (USA, Brazil) as soon as possible in 2023, said Biophytis CEO Stanislas Veillet.

BPTS +31.75% to $0.78 premarket Nov. 3

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