DBV’s drug fails to meet primary endpoint in Phase III peanut allergy trial

23rd October 2017 (Last Updated October 23rd, 2017 00:00)

DBV Technologies has reported top-line results from the Peanut EPIT Efficacy and Safety (PEPITES) Phase III clinical trial of Viaskin Peanut conducted in patients aged from four to 11 years suffering from nut allergies.

DBV’s drug fails to meet primary endpoint in Phase III peanut allergy trial
DBV studies peanut allergy drug in children. Credit: Daniella Segura/Flickr.

DBV Technologies has reported top-line results from the Peanut EPIT Efficacy and Safety (PEPITES) Phase III clinical trial of Viaskin Peanut conducted in patients aged from four to 11 years suffering from nut allergies.

The firm’s immunotherapy technology Viaskin involves administration of allergen directly into the superficial layers of the skin, where it activates immune system by targeting antigen-presenting cells.

According to the top-line data, 35.3% of subjects achieved a significant response to 250μg Viaskin Peanut following 12 months of treatment, compared to 13.6% with placebo.

The results further showed that the drug did not meet the primary endpoint of 15% lower bound of the confidence interval (CI) in the difference in response rates between the investigational and placebo groups.

Conducted at 31 centres across North America, Germany, Ireland and Australia, the double-blinded, placebo-controlled Phase III PEPITES trial assessed the safety and efficacy of Viaskin Peanut.

"The findings in this study underscore the potential of epicutaneous immunotherapy."

DBV Technologies chief scientific officer Dr Hugh Sampson said: “The findings in this study underscore the potential of epicutaneous immunotherapy, and we continue to be encouraged by the response rate and clinically meaningful improvements in cumulative reactive dose that we observed.

“We believe the strength of all clinical data we have seen to date in over 650 patients supports the safety and efficacy profile of Viaskin Peanut, and look forward to seeing the full results from this trial.”

The results also revealed a statistically significant increase in a secondary endpoint measure of cumulative reactive dose (CRD) from 210mg at baseline to 900mg at month 12 with Viaskin Peanut.

Viaskin Peanut demonstrated favourable safety and tolerability profile consistent with previous data from a Phase IIb trial.