FDA Imposes Partial Hold On DBV Technologies' Phase III VITESSE Study

DBV Technologies' (DBVT) phase III study of modified Viaskin Peanut 250 µg patch, dubbed VITESSE, has been slapped with a partial clinical hold by the FDA.

VITESSE is a phase III, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years.

The company has not yet begun the screening or recruitment of subjects in the VITESSE study.

The partial hold has been imposed following changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission.

The modifications address design elements of the study, 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, noted the company.

DBVT is currently down over 9% trading at $2.

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