Brief: Biophytis Says 'Promising' Top Line Results In COVID Study

Biophytis SA

07/09/2022 07:07

Sept 7 (Reuters) - BIOPHYTIS SA  ALBPS.PA :
    * BIOPHYTIS ANNOUNCES VERY PROMISING TOP LINE RESULTS OF ITS
PHASE
2-3 COVA CLINICAL STUDY IN COVID-19-RELATED RESPIRATORY FAILURE
    * FURTHER DATA ANALYSIS IS STILL ONGOING
    * INTENDS TO MAKE THIS NEW THERAPEUTIC SOLUTION AVAILABLE TO
COVID-19 HOSPITALIZED PATIENTS AT RISK OF RESPIRATORY FAILURE
AND EARLY DEATH
    * 233 TREATED PATIENTS WERE 63 YEARS OLD ON AVERAGE, 64% OF
PATIENTS WERE MALE, RECRUITED IN CENTERS IN EUROPE, US AND
BRAZIL BETWEEN Q3 2020 AND Q1 2022, INFECTED WITH MAIN
SARS-COV-2 VARIANTS
    * IN PRIMARY ANALYSIS, SARCONEOS (BIO101) REDUCED BY 39%
RISK OF
RESPIRATORY FAILURE OR EARLY DEATH AT 28 DAYS (PRIMARY ENDPOINT)
COMPARED TO PLACEBO (15.8% VERSUS 26.0%, ADJUSTED DIFFERENCE
11.8% IN FAVOR OF TREATMENT, P=0.07)
    * SARCONEOS (BIO101) REDUCED BOTH PROPORTION OF PATIENTS
WITH
RESPIRATORY FAILURE (12.7% VERSUS 21.5%) AND EARLY DEATH (0.8%
VERSUS 2.8%)
    * SARCONEOS (BIO101) ALSO SIGNIFICANTLY (P=0.03) DELAYED
PROGRESSION OF RESPIRATORY FAILURE OR EARLY DEATH OVER 28 DAYS
MAXIMUM TREATMENT PERIOD
    * IN ADDITION, IN THIS PRIMARY ANALYSIS, SARCONEOS (BIO101)
REDUCED RISK OF DEATH AT 28 DAYS COMPARED TO PLACEBO, IN SIMILAR
PROPORTION TO OBSERVED REDUCTION IN RISK OF RESPIRATORY FAILURE
OR EARLY DEATH AND DELAYED ITS OCCURRENCE WITHIN 90 DAYS

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