133 0 Kommentare DBV Technologies Announces Publication of PEOPLE Phase III Open-Label Extension Study Evaluating Viaskin Peanut in The Journal of Allergy and Clinical Immunology

Montrouge, France, July 7, 2020

DBV Technologies Announces Publication of PEOPLE Phase III Open-Label Extension Study Evaluating Viaskin Peanut in The Journal of Allergy and Clinical Immunology

PEOPLE is the largest long-term peanut allergy immunotherapy trial to date and showed favorable benefit-to-risk across three-year treatment period with Viaskin Peanut

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that The Journal of Allergy and Clinical Immunology (JACI) has published results from its three-year, open-label extension of the Phase III PEPITES study (PEOPLE). The study was published online today and will be in an upcoming print edition of the journal.

Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment with Viaskin Peanut (compound name DBV712 250 μg), with low discontinuations due to adverse events. Top-line data from PEOPLE were announced in January 2020 and presented with additional detail at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Annual Meeting in March. The Biologics License Application (BLA) for investigational DBV712 for peanut-allergic children ages 4-11 years is currently under review by the U.S. Food and Drug Administration (FDA). If approved, DBV712 would be the first once-daily, non-invasive epicutaneous treatment option for children living with peanut allergy.

“These data from the largest long-term study of peanut allergy immunotherapy demonstrate continued treatment benefit of DBV712 beyond one year, as well as a decrease in adverse events,” said David Fleischer, M.D., Principal Investigator of PEPITES and PEOPLE, Professor of Pediatrics and Section Head, Children’s Hospital Colorado. “In my clinical practice, I see many patients and their families who struggle with the burden of peanut allergy and the fear of accidental exposure. The potential benefit of an easy to use, well-tolerated treatment with long-term effect would be a welcome option for these patients.”

PEOPLE Efficacy Results
Data from the PEOPLE trial demonstrate that DBV712 was associated with continued response over a three-year treatment period.

75.9% (107/141) saw an improvement in eliciting dose (ED) from baseline to Month 36.
51.8% (73/141) achieved an ED of at least 1,000 mg at Month 36.
At Month 36, the mean cumulative reactive dose (CRD) was 1,768.8 mg (median 944 mg) compared to 223.8 mg (median 144 mg) at baseline.
A treatment effect was seen across the spectrum of baseline sensitivity, including the most sensitive patients; those who entered with an ED of less than or equal to 10 mg (n=18) saw a 22.5-fold increase in geometric mean ED over the treatment period.
Consistent with the high rate of sustained unresponsiveness reported in a previous clinical study1, exploratory analyses in a subset of participants showed that 77.8% (14/18) were able to maintain desensitization, according to predefined study definition, for a two-month period while off therapy and without peanut consumption.