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DBV Technologies (DBV) investor relations material
DBV Technologies Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Industry interest and unmet need
Food allergy affects 17–33 million Americans, with 700,000 children impacted by peanut allergy alone, representing a significant unmet need in healthcare.
Advances in science and promising developments are attracting capital and attention to the food allergy space.
Technology and clinical programs
The company’s epicutaneous immunotherapy (EPIT) patch, VIASKIN, targets desensitization in children with peanut allergies, focusing on ages one to seven.
Two parallel programs use similar patch technology: a square patch for ages one to four and a round patch for ages four to seven, with independent BLAs planned.
BLA filing for ages four to seven is planned for the first half of next year, and for ages one to three in the second half of next year.
Clinical trial design and data
The VITESSE trial in four to seven-year-olds is the largest of its kind, enrolling 654 subjects, with a primary efficacy endpoint based on responder rates and a 15% lower bound confidence interval.
Prior data from the Papeete study in a similar age group showed a 34–35% delta in response rate, and VITESSE is powered above 90% with conservative assumptions.
Safety is a key focus, with previous studies showing a strong safety profile and high compliance; local skin reactions are the most common side effect, typically mild and decreasing over time.
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