Brief: Theranexus And BBDF Granted Positive Opinion By EMA For Design Of Batten-1 Phase III Trial

Thx Pharma SA

07/06/2023 06:49

June 7 (Reuters) - Theranexus SA  ALTHX.PA :
    * THERANEXUS AND BBDF GRANTED POSITIVE OPINION BY EMA FOR
THE
DESIGN OF PHASE III TRIAL TO EVALUATE BATTEN-1 IN CLN3 BATTEN
DISEASE
    * EMA'S RESPONSE IS CONSISTENT WITH TERMS OF APPROVAL
RECEIVED
FROM FOOD AND DRUG ADMINISTRATION IN EARLY MAY 2023
    * PATIENT ENROLLMENT IS EXPECTED TO BEGIN BY LATE 2023
    * TRIAL WILL RUN IN PARALLEL IN SEVERAL CENTERS THROUGHOUT
UNITED
STATES AND EUROPE
    * INTERIM RESULTS WILL BE PRODUCED EVERY 6 MONTHS ON SAME
EFFICACY
AND TOLERABILITY ENDPOINTS AS MAIN 60 PATIENT COHORT, WHICH WILL
ENABLE COMPANY TO COLLECT CLINICAL DATA AT AN EARLY STAGE
    * AIMING FOR PRODUCT APPROVAL IN THESE COUNTRIES FOLLOWED BY
FIRST
SALES IN 2027

Source text for Eikon:  ID:nACT80305 
Further company coverage:  ALTHX.PA 

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