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Treatment compliance remained high throughout PEPITES and PEOPLE at a mean of 98%. Most withdrawals were due to
fear or aversion to a double-blind, placebo-controlled food challenge.
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We are pleased that JACI has published the PEOPLE
trial results, ensuring that healthcare providers will have access to these important data supporting an epicutaneous immunotherapy approach to treating one of the most common food allergies in children, said Pharis Mohideen, M.D., Chief
Medical Officer of DBV Technologies, We believe that data from this landmark study in peanut-allergic children ages 4-11 support the potential long-term treatment benefit in this patient
population.
About PEOPLE
The PEOPLE study
is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut (DBV712 250 µg) (NCT03013517). Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE. Patients who were randomized to active treatment in PEPITES are eligible to receive up to four additional years of treatment, and those previously
receiving placebo are eligible to receive up to five years of treatment.
The study evaluates the eliciting dose after three years (Month 36) of active
treatment using a double-blind, placebo-controlled food challenge (DBPCFC). The starting dose of each challenge is 1 mg of peanut protein and escalates to the highest dose of 2,000 mg peanut protein (possibly repeated once to reach a maximum total
cumulative dose of 5,444 mg peanut protein). For the planned DBPCFCs after four and five years of treatment, the starting dose of each challenge is 10 mg of peanut protein and escalates to the highest dose of 3,000 mg peanut protein (possibly
repeated once to reach a maximum total cumulative dose of 6,440 mg peanut protein).
The analysis also includes exploratory assessments of safety
parameters, immune biomarkers such as immunoglobulin E (IgE) and immunoglobulin G4 (IgG4), and sustained unresponsiveness following a two-month period without treatment.
About DBV Technologies
DBV Technologies is developing
Viaskin®, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT, DBVs method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product
candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBVs food allergies programs include ongoing clinical trials of Viaskin Peanut (DBV712). DBV Technologies has global headquarters in Montrouge,
France and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. The Companys ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and
the Companys ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).