Brief: Biofrontera Announces Initiation Of Two Clinical Studies

Biofrontera AG

16/11/2021 13:59

Nov 16 (Reuters) - BIOFRONTERA AG  B8FGn.DE :
    * ANNOUNCES INITIATION OF CLINICAL STUDIES
    * TWO CLINICAL STUDIES FOR ITS PRESCRIPTION DRUG AMELUZ® IN
UNITED
STATES ARE BEING STARTED WITH SITE INITIATIONS CURRENTLY IN
PROGRESS
    * SEVEN SITES FOR PHASE TWO STUDY FOR TREATMENT OF MODERATE-
TO-
SEVERE ACNE IN ADULTS AS WELL AS EIGHT SITES FOR PHASE I SAFETY
STUDY EVALUATING SAFETY OF PHOTODYNAMIC THERAPY (PDT) WITH
SIMULTANEOUS APPLICATION OF THREE TUBES OF AMELUZ®
    * BOTH STUDIES ARE FOCUSED ON OPTIMIZING MARKET POSITIONING
AND
EXPANDING MARKET SHARE FOR OUR FDA-APPROVED PRESCRIPTION DRUG
AMELUZ® FOR PHOTODYNAMIC THERAPY IN OUR LARGEST MARKET, UNITED
STATES," SAYS HERMANN LÜBBERT, CEO
    * SECOND STUDY IS A NON-RANDOMIZED, OPEN-LABEL, MULTICENTER
STUDY
TO EVALUATE SAFETY AND TOLERABILITY OF AMELUZ IN TREATMENT OF AK
LOCATED ON FACE AND SCALP WITH PDT TOGETHER WITH NEW
BF-RHODOLED® XL LAMP
    * STUDY INCLUDES 100 PATIENTS WITH MILD TO SEVERE AK. EACH
PATIENT
WILL RECEIVE CONTENT OF 3 TUBES OF AMELUZ FOR A FIELD-DIRECTED
TREATMENT. THIS STUDY COMES ON BACK OF A MAXIMAL-USAGE
PHARMACOKINETICS (PK) CLINICAL STUDY COMPLETED IN EARLY 2021

Source text for Eikon:  ID:nPexXp2DYa 
Further company coverage:  B8FGn.DE 

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