DBV Technologies: PEPITES trial does not reach primary endpoint
DBV Technologies announced topline results from the PEPITES, or Peanut EPIT Efficacy and Safety, Phase III trial evaluating the safety and efficacy of Viaskin Peanut in children four to 11 years of age. Topline results show a statistically significant response with a favorable tolerability profile, with 35.3% of patients responding to Viaskin Peanut 250 microg after 12 months of treatment as compared to 13.6% of patients in the placebo arm. However, the primary endpoint, which evaluates the 95% confidence interval in the difference in response rates between the active and placebo arms, did not reach the 15% lower bound of the CI that was proposed in the study's Statistical Analysis Plan submitted to the U.S Food and Drug Administration. Following initial conversations with the FDA on these topline efficacy and safety results, DBV will continue ongoing discussions with the agency, and plans to proceed with the BLA preparation process. "We believe that this preliminary analysis shows significant therapeutic promise in the peanut-allergic population, where there is a high unmet medical need and no approved treatments," said Dr. Pierre-Henri Benhamou, Chairman & Chief Executive Officer of DBV Technologies. "Viaskin Peanut has been granted both Breakthrough Therapy and Fast Track designations by the FDA for the treatment of peanut allergy. We are committed to working together with the regulatory agencies to bring forward a safe and effective treatment option for these patients."