Brief: Poxel/PXL065: Positive Results From Phase 2 Nash Trial

Poxel SA

07/03/2023 06:35

March 7 (Reuters) - Poxel Sa  POXEL.PA :
    * POXEL ANNOUNCES PUBLICATION OF POSITIVE PHASE 2 RESULTS
FROM
PHASE 2 NASH TRIAL (DESTINY-1) FOR PXL065 IN JOURNAL OF
HEPATOLOGY
    * POXEL ANNOUNCES PUBLICATION OF POSITIVE PHASE 2 RESULTS
FROM
PHASE 2 NASH TRIAL (DESTINY-1) FOR PXL065 IN JOURNAL OF
HEPATOLOGY
    * PXL065 PHASE 2 TRIAL FOR THE TREATMENT OF NASH MET ITS
PRIMARY
EFFICACY ENDPOINT FOR LIVER FAT CONTENT REDUCTION AT 36-WEEKS
FOR ALL DOSES
    * FIBROSIS IMPROVEMENT BY >1 STAGE WITHOUT WORSENING OF
NASH, AN
ENDPOINT RECOGNIZED BY FDA FOR APPROVAL, OCCURRED IN 31-50%
PATIENTS IN THE PXL065 STUDY ARMS VERSUS. 17% WITH PLACEBO.
    * VALIDATION OF PXL065 HYPOTHESIS - COMBINING EFFICACY ON
LIVER
AND METABOLIC ENDPOINTS WITH REDUCED POTENTIAL FOR PPARG SIDE
EFFECTS (WEIGHT GAIN AND EDEMA)
    * PRIMARY EFFICACY ENDPOINT WAS ACHIEVED: A STATISTICALLY
SIGNIFICANT (P=0.024 TO P=0.008) MEAN RELATIVE DECREASE VERSUS.
PLACEBO OF 21% TO 25% IN LIVER FAT CONTENT FROM BASELINE TO 36
WEEKS WAS OBSERVED AT ALL PXL065 DOSES
    * HISTOLOGY: FIBROSIS IMPROVEMENT BY >1 STAGE WITHOUT
WORSENING OF
NASH, AN ENDPOINT RECOGNIZED BY FDA FOR APPROVAL, OCCURRED IN
31-50% PATIENTS IN THE PXL065 STUDY ARMS VERSUS. 17% WITH
PLACEBO. ACROSS ALL PXL065 TREATMENT ARMS (POOLED DATA), 39% OF
PATIENTS HAD FIBROSIS IMPROVEMENT BY ≥1 STAGE WITHOUT WORSENING
NASH (%) VERSUS. 17% WITH PLACEBO.

Source text for Eikon:  ID:nBw2jNhwCa 
Further company coverage:  POXEL.PA 

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