Brief: AB Science Receives Approval From FDA To Initiate Phase 3 Study With Masitinib

AB Science SA

29/12/2022 17:11

Dec 29 (Reuters) - AB Science SA  ABS.PA :
    * AB SCIENCE HAS RECEIVED APPROVAL FROM THE U.S. FOOD AND
DRUG
ADMINISTRATION (FDA) TO INITIATE THE CONFIRMATORY PHASE 3 STUDY
WITH MASITINIB IN THE TREATMENT OF PROGRESSIVE MULTIPLE
SCLEROSIS
    * STUDY AB20009 IS ACTIVELY RECRUITING PATIENTS
    * STUDY WILL ENROLL 800 PATIENTS FROM NUMEROUS STUDY CENTERS
    * PRIMARY ENDPOINT OF STUDY IS EFFECT OF MASITINIB ON TIME
TO
CONFIRMED DISABILITY PROGRESSION.
    * OBJECTIVE OF THIS STUDY IS TO CONFIRM POSITIVE RESULTS
FROM THE
PHASE 2B/3 STUDY (AB07002).

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