The biopharmaceutical company DBV Technologies is due to begin two safety trials for Viaskin Peanut in two age groups, known as COMFORT Toddlers and COMFORT Children. The aim is to gain approval for skin patches for young children to improve their tolerance of peanuts.
The peanut allergy patch met the primary endpoints in the Phase III EPITOPE trial in toddlers aged 1-3 years in 2022, but received feedback on safety requirements from the US Food and Drug Administration (FDA) in April. DBV Technologies have now streamlined the protocol designs for both of the new safety trials
DBV Technologies are seeking approval for the skin patches for two age groups, toddlers (aged one-three years) and young children (aged four-seven years), and are expected to begin enrolment for toddlers in early 2024. Once COMFORT toddlers has started, recruitment will begin for children.
Changes to the study design include a food challenge test to establish peanut allergy in toddlers, but not in children, in addition to the peanut-specific IgE and skin prick test. The product guidance has also been updated using simpler language, stating the skin patches need to be worn for 24 hours.
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