DBV Technologies announces results from OLE to EPITOPE trial

DBV Technologies announced interim results from its ongoing Open-Label Extension, or OLE, study of EPITOPE, which is named EPOPEX. After completing participation in the EPITOPE study, eligible subjects could enroll in EPOPEX to receive a total of three years of Viaskin Peanut treatment. Double-blind placebo-controlled food challenges are conducted at the end of each year of treatment with safety assessed throughout the entire OLE. Importantly, all subjects remained blinded to their treatment assignment in EPITOPE until every patient completed EPITOPE and the database was locked; therefore, the decision to enter the OLE was not biased by the unblinding of the randomized treatment. In total, 244 subjects were randomized to the active arm of EPITOPE with 208 completing the study. 85% of eligible subjects entered the OLE with 95% participating in the DBPCFC at Month 24 of Viaskin Peanut 250 microgram treatment. Similar percentages were observed for the subjects randomized to the placebo arm of EPITOPE: 92% of eligible subjects entered the OLE with 86% participating in the DBPCFC at Month 12 of VP 250 treatment. The 175 and 91 subjects presented in the OLE cohorts are a subset of the subjects presented in the EPITOPE 12-month results. After 24 months of VP250, all efficacy parameters demonstrated an increase in treatment response relative to the corresponding EPITOPE 12-month results: 81.3% of participants reached an eliciting dose, or ED, greater than or equal to 1000 mg, or approximately 3-4 whole peanut kernels. 63.8% reached an ED greater than or equal to2000 mg. 55.9% completed the cumulative 3,444 mg DBPCFC without meeting stopping criteria. Using the EPITOPE primary endpoint definition, 83.9% of subjects were responders. Month-12 assessment of the efficacy parameters in the EPITOPE subjects that entered the OLE further demonstrates the improvement in treatment response following an additional 12 months of treatment. At month 12, 74.7%, reached an eliciting dose greater than or equal to 1000 mg relative to 81.3% at Month 24. At month 12, 52.4% reached an ED greater than or equal to2000 mg relative to 63.8% at Month 24. The proportion who completed the cumulative 3,444 mg DBPCFC without meeting stopping criteria was 39.5% and 55.9%, at months 12 and 24, respectively. Using the EPITOPE primary endpoint definition, 77.4% were responders at Month 12 relative to 83.9% at month 24. 47.2% of subjects that did not meet EPITOPE responder criteria at Month 12 did meet the responder criteria at Month 24. No treatment-related anaphylaxis or serious treatment-related adverse events occurred in the second year of active treatment. The frequency of local application site reaction decreased in the second year of treatment. Efficacy results for subjects that entered the OLE from the placebo arm of EPITOPE: 62.7% reached an ED greater than or equal to 1000 mg, 36.5% reached an ED greater than or equal to2000 mg, 28.4% completed the DBPCFC without meeting stopping criteria and 68.0% met the EPITOPE responder definition. These results were consistent with the EPITOPE VP250 arm results. The safety data for this group were consistent with what was observed in EPITOPE. There was a single event of treatment-related anaphylaxis.