DBV Technologies Advances Peanut Allergy Program With FDA Support On Pediatric Studies

DBV Technologies DBVT received Type C meeting written responses from the FDA on key study design elements for the COMFORT Toddlers and COMFORT Children supplemental safety studies in 1 – 3-year-olds and 4 – 7-year-olds, respectively, with a peanut allergy. 

The COMFORT Toddlers safety study will enroll peanut-allergic toddlers ages 1 – 3 years and support the efficacy results generated from the EPITOPE Phase 3 pivotal study. 

The COMFORT Children safety study will enroll peanut-allergic children ages 4 – 7 years and support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study.

The FDA agreed with a 6-month study duration and a 3:1 randomization (active: placebo) of approximately 400 subjects in the COMFORT Toddlers study. 

Both COMFORT studies will assess adhesion using the same tools and measurements established in VITESSE. 

Both the COMFORT studies do not require an oral food challenge for participation.

Both COMFORT studies aim to bring the total number of subjects on active treatment to approximately 600 participants in each age group when added to their respective Phase 3 pivotal efficacy studies (i.e., EPITOPE and VITESSE).

The company reported Q2 sales of $2.28 million, up from $1.53 million a year ago.

The company reported an EPS loss of $(0.26) down from $(0.35) a year ago.

DBV closes Q2 2023 with a cash balance of $174 million.

Price Action: DBVT shares are up 8.11% at $1.60 during the premarket session on the last check Tuesday.