Montrouge, France, September 21, 2022
DBV Technologies Provides Clinical Update on VITESSE Phase 3 Trial
DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that it received feedback from the U.S. Food and Drug Administration (FDA) in the form of a partial clinical hold on its VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 clinical study.
In the partial clinical hold letter, the FDA specifies changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission. Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment.
DBV has not yet begun the screening or recruitment of subjects in the VITESSE study. The partial clinical hold is specific to VITESSE and does not impact any other ongoing DBV clinical studies. The Company expects to provide additional updates following consultation with the FDA.
“We are grateful for the FDA’s additional feedback reflecting careful attention to DBV’s VITESSE study,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “We are pleased that the comments …