Montrouge, France, September 21, 2022
DBV Technologies Provides clinical update on Phase 3 VITESSE study
DBV Technologies DBVTFa clinical-stage biopharmaceutical company, announced today that it has received feedback from the U.S. Food and Drug Administration (FDA) of a partial clinical ban of its VITESSE (viaskin peanut Iimmunotherapy Trials to Eevaluate SSecurity, Smatter of course and EEfficacy) Phase 3 clinical study.
In the partial clinical hold letter, the FDA specifies changes to elements of the VITESSE protocol with the intent that the study will support future BLA submission. In the FDA’s notice, the changes address design elements, including statistical analysis of adhesion, minimum daily wear time, and technical alignment of methods used to categorize data to meet study objectives and total number of study participants on active treatment.
DBV has not yet started screening or enrolling subjects in the VITESSE study. The partial clinical suspension is specific to VITESSE and will not impact other ongoing DBV clinical trials. The company expects to provide further updates after consultation with the FDA.
“we are thankful for the FDA additionally freturn message reflective careful attention VITESSE study by the DBV”, said Daniel Tassé, CEO of DBV Technologies. “We are pleased that the comments to protocol are Specific, clear and before arrived enrollment. We look look forward to future discussions with key FDA staff.”
VITESSE is a double-blind, placebo-controlled, randomized phase 3 study to evaluate the efficacy and safety of patch immunotherapy with the modified Viaskin™ Peanut 250 µg patch in peanut-allergic children aged 4 to 7 years.
About DBV Technologies
DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad application potential in immunotherapy. Viaskin is based on epicutaneous immunotherapy or EPIT™ and is DBV Technologies’…
