DBV: DSMB Review Positive In Viaskin Peanut Part A Study; To Start Part B In Q4

(RTTNews) - DBV Technologies (DBVT), a clinical-stage biopharmaceutical company, announced Wednesday positive review by Data and Safety Monitoring Board or DSMB of Part A of Phase III study in peanut-allergic toddlers.

The company said the independent DSMB completed its planned safety review of Part A of the EPITOPE (EPIT in TOddlers with PEanut Allergy) trial of Viaskin Peanut in peanut-allergic toddlers ages one to three.

Following this positive DSMB recommendation, the company plans to initiate Part B of the EPITOPE study in the fourth quarter of 2018 to assess the efficacy and safety of Viaskin Peanut 250 µg for 12 months.

The DSMB did not identify any safety concerns for patients enrolled in Part A of the trial, recommending that the study continue as planned with the 250 µg dose selected for investigation in Part B.

Part A enrolled 51 patients at seven centers in the United States.

EPITOPE is expected to enroll approximately 400 patients, including 350 in Part B, in approximately 35 - 50 centers across North America, Europe, and Australia.

Following the completion of EPITOPE, all eligible patients will have the option to rollover into EPOPEX, a long-term, open-label extension study of Viaskin Peanut 250 µg. In the EPOPEX study, patients who were randomized to active treatment during EPITOPE will receive Viaskin Peanut 250 mcg for two additional years; patients who were previously receiving placebo during EPITOPE will be treated with Viaskin Peanut 250 mcg for three years.

Patients enrolling in the EPOPEX study will remain blinded to their respective treatment group in EPITOPE until the EPITOPE study results become publicly available.