DBV Technologies

Data at AAAAI 2017 Show Lasting Response and Favorable Safety Profile of Investigational Agent, Viaskin Peanut, Throughout Three Years of Treatment of Peanut Allergic Children - Seite 3

Dr. Baumert's presentation showed that increasing an individual's peanut protein threshold, or eliciting dose, following immunotherapy would provide a significant relative risk reduction. A greater than 99% relative risk reduction was associated with reaching a post-therapy threshold of 300 mg if the individual's initial eliciting dose was less than or equal to 10 mg, or reaching a post-therapy threshold of 1,000 mg, if the individual's initial eliciting dose was less than or equal to 300 mg.

The study was conducted using a Quantitative Risk Assessment (QRA) model developed independently by FARRP, a leading institution focused on providing expertise on allergenic foods and food safety. The robust QRA model used common packaged food items such as cookies, ice cream, doughnuts/snack cakes and snack chip mixes as references for this risk assessment. DBV provided funding for the study and formulated the research question as related to the VIPES Phase IIb clinical trial of Viaskin Peanut.

"This meeting at AAAAI has been filled with exciting data that highlights Viaskin and its potential in food allergies. Our presence at AAAAI involves six poster presentations and two oral presentations, including long-term results from OLFUS-VIPES and important findings from FARRP, which emphasize our commitment to developing a patient-centric, safe and effective treatment for peanut allergy," said Dr. Pierre-Henri Benhamou, Chairman & Chief Executive Officer of DBV Technologies. "We are very proud of these clinical and research accomplishments, and I would like to thank all of our patients and investigators for their support and continued efforts in moving the Viaskin Peanut development program forward. The results we have shown over the past couple of days highlight our dedication to bringing a treatment to peanut-allergic patients as quickly as possible."

About the OLFUS-VIPES Study
OLFUS-VIPES (Open-Label Follow-Up Study-Viaskin Peanut's Efficacy and Safety), or OLFUS, enrolled 171 subjects who had previously received either placebo or one of three 12-month dose regimens administered during VIPES. During the first year of OLFUS, patients were to receive a daily application of Viaskin Peanut 50 µg or Viaskin Peanut 100 µg or Viaskin Peanut 250 µg for 12 months. According to a study protocol change implemented in March 2014, all patients were switched to receive Viaskin Peanut 250 microg during OLFUS. All patients in OLFUS maintained a peanut-free diet during the study. Baseline response levels in OLFUS were based on the results of the last double-blind, placebo controlled food challenge (DBPCFC) in VIPES, and adjusted by the number of patients enrolling in OLFUS. Responders in the OLFUS trial were defined as subjects with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut protein or with a greater than 10-fold increase of the eliciting dose compared to their baseline eliciting dose observed in the VIPES study. Patients enrolled in OLFUS who received placebo in VIPES were analyzed separately from subjects who initially received Viaskin Peanut. At month 24 in OLFUS, patients who were unresponsive to a cumulative dose above 1,440 mg were eligible to discontinue study drug for two months while maintaining a peanut-free diet. Patients who opted to enter into this additional period performed a DBPCFC at month-26 to assess durability of response.