Brief: Axcella Announces Positive Top-Line Data From AXA1125-003 Clinical Study Showing Multifactorial Activity In Adult Subjects With NAFLD

Axcella Health

06/05/2020 13:09

May 6 (Reuters) - Axcella Health Inc  AXLA.O :
    * AXCELLA ANNOUNCES POSITIVE TOP-LINE DATA FROM AXA1125-003
CLINICAL STUDY SHOWING MULTIFACTORIAL ACTIVITY IN ADULT SUBJECTS
WITH NAFLD
    * AXCELLA HEALTH INC - GREATER ACTIVITY IN KEY MARKERS SEEN
AMONG
SUBJECTS WITH TYPE 2 DIABETES RECEIVING AXA1125
    * AXCELLA HEALTH - PLANS TO ENGAGE WITH FDA ABOUT IND
SUBMISSION
FOR AXA1125, PROPOSED PHASE 2B CLINICAL TRIAL IN ADULT NASH &
PEDIATRIC DEVELOPMENT PROGRAM
    * AXCELLA HEALTH INC - RESULTS FROM STUDY SHOWED THAT
AXA1125 AND
AXA1957 WERE GENERALLY WELL-TOLERATED
    * AXCELLA HEALTH - STUDY SHOWED SUSTAINED REDUCTIONS FOR
AXA1125
AND AXA1957 VERSUS PLACEBO IN KEY BIOMARKERS OF METABOLISM,
INFLAMMATION & FIBROSIS OVER 16 WEEKS
    * AXCELLA HEALTH - OVERALL, COMPARED TO PLACEBO, AXA1125
SHOWED
LARGER AND MORE CONSISTENT REDUCTIONS IN CLINICALLY RELEVANT
BIOMARKERS THAN AXA1957
    * AXCELLA HEALTH - TWO SERIOUS ADVERSE EVENTS WERE REPORTED
IN
AXA1125 & AXA1957 STUDY, BOTH DETERMINED TO BE UNRELATED TO
STUDY PRODUCT ADMINISTRATION
    * AXCELLA HEALTH - DECIDED THAT WE WILL NOT REINITIATE
AXA1957-002
PEDIATRIC STUDY, WHICH HAD RECENTLY BEEN SUSPENDED DUE TO
COVID-19

Source text for Eikon:  ID:nBw475L3Ma 
Further company coverage:  AXLA.O 

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