- The FDA has instituted a partial clinical hold on DBV Technologies SA’s DBVT VITESSE Phase 3 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.
- 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 marketing application 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 and the total number of trial participants on active treatment.
- DBV has not yet begun screening or recruiting subjects in the VITESSE study.
- The partial clinical hold is specific to VITESSE and does not impact any other ongoing DBV clinical studies.
- DBV started the trial earlier this month and expected to enroll 600 subjects. The first patient screened is expected in Q4 2022, with the last patient screened by year-end 2023.
- In June, the company announced positive results from the pivotal Phase 3 EPITOPE trial of Viaskin Peanut 250 µg for peanut-allergic toddlers ages 1 to 3 years.
- Price Action: DBVT shares closed 14% lower at $1.90 during after-hours trading on Wednesday.
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