DBV to submit final COMFORT Toddlers protocols to FDA in ‘coming weeks’

DBV Technologies announced the receipt of written feedback from the U.S. Food and Drug Administration FDA regarding the remaining study design elements for the COMFORT, Characterization of the Optimal Management of FOod Allergy Relief and Treatment,supplemental safety studies. T …Following DBV’s request for clarification after receipt of Type C Meeting feedback in July 2023, the FDA provided Written Responses on protocol design elements for the COMFORT supplemental safety studies. Both COMFORT Toddlers and COMFORT Children protocol will have harmonized language guiding how the product will be used in the trials, such as, “Each DBV712 250 microgram epicutaneous system is intended to be worn for a full day.” …”We are very pleased with the engagement and clarity of the feedback received from the FDA,” stated Pharis Mohideen, Chief Medical Officer of DBV Technologies. “With a clear regulatory path forward, we will submit to FDA the final protocols for the COMFORT studies. We remain confident that this work will support a Biologics License Application BLA in both age groups and potentially bring this novel, much needed therapy to a vulnerable patient population.” DBV will implement the FDA’s feedback and expects to submit the final COMFORT Toddlers protocol design to the Agency in the coming weeks. DBV anticipates the first subject will be enrolled in Q1 2024. The initiation of COMFORT Children is expected after the start of COMFORT Toddlers and in alignment with VITESSE recruitment.