Brief: Poxel Announces Positive Results For PXL065 Phase 1B Trial

Poxel SA

18/12/2019 07:09

Dec 18 (Reuters) - POXEL SA  POXEL.PA :
    * POXEL ANNOUNCES POSITIVE RESULTS FOR PXL065 PHASE 1B TRIAL
AND
PROVIDES PROGRAM UPDATE
    * IN 2Q 2020, POXEL PLANS TO INITIATE A PHASE 2 36-WEEK
TRIAL IN
BIOPSY-PROVEN NASH PATIENTS DESIGNED TO IDENTIFY OPTIMAL DOSE OR
DOSES FOR PHASE 3 REGISTRATION TRIAL
    * 13-WEEK REPEATED-DOSE TOXICITY STUDY IN DOGS WAS OBSERVED
TO
SHOW AN IMPROVED SAFETY MARGIN OVER PIOGLITAZONE
    * PXL065 PHASE 1B MULTIPLE ASCENDING DOSE TRIAL WAS OBSERVED
TO
DEMONSTRATE A DOSE-PROPORTIONAL PHARMACOKINETIC PROFILE AND
CONSISTENT STABILIZATION OF R-PIOGLITAZONE AT ALL DOSES TESTED
    * PXL065 IS BEING DEVELOPED USING 505(B) REGULATORY PATHWAY,
WHICH
OFFERS OPPORTUNITY FOR STREAMLINED AND EFFICIENT DEVELOPMENT
PROGRAM
    * WE PLAN TO INITIATE A PHASE 2 TRIAL FOR PXL065 IN
BIOPSY-PROVEN
NASH PATIENTS DURING Q2 OF 2020-CEO

Source text for Eikon:  ID:nBwW6B5ga 
Further company coverage:  POXEL.PA 

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