The FDA has placed a partial clinical hold on DBV Technologies’ peanut allergy drug phase 3 trial, the French biotech announced this week.
The trial, called VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity, and Efficacy) intends to assess the safety and efficacy of Viaskin, the immunotherapeutic drug that is applied as a patch. The patch works by containing a deposit of dry allergen at its center, which is captured by antigen-presenting cells. Because the drug mechanism does not penetrate the allergen beyond the epidermis, immune cells are able to migrate the allergen to the lymph nodes where they induce specific T-cells that are capable of suppressing allergic responses.
In its recent statement, DBV went on to explain that the clinical hold letter specified changes to elements of the trial protocol that would help support a future Biologics License Application. "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," the company also said.