DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin Peanut in Toddlers

Montrouge, France, November 9, 2023

DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin Peanut in Toddlers

• Viaskin Peanut showed improvement between months 12 and 24 of treatment across all efficacy parameters. Notably, 81.3% of subjects who completed the oral food challenge reached an eliciting dose of ≥1,000 mg after 24 months of treatment.
• 55.9% of subjects completed the oral food challenge at a cumulative dose of 3,444 mg without meeting stopping criteria.
• Among treatment-arm subjects from EPITOPE, there were no treatment-related anaphylactic or serious treatment-related adverse events in the second year of active treatment.
• DBV to highlight EPOPEX results in late-breaking oral abstract presentation at the American College of Allergy, Asthma, and Immunology (ACAAI) annual meeting on Saturday, November 11^th at 9:35AM PT.
• Company to host investor conference call and webcast at 5:00pm ET today, Thursday, November 9^th, to discuss the results.
  
  

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive interim results from its ongoing Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of Viaskin Peanut 250 µg [VP250] in toddlers ages 1 to 3 years), 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 (DBPCFC) 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.

Twelve-Month EPITOPE OLE Interim Results:

• 244 subjects were randomized to the active arm of EPITOPE with 208 completing the study. 85% of eligible subjects (175 of 208) entered the OLE with 95% (166 of 175) participating in the DBPCFC at Month 24 of Viaskin Peanut 250 µg (“VP250”) treatment. Similar percentages were observed for the subjects randomized to the placebo arm of EPITOPE: 92% of eligible subjects (91 of 99) entered the OLE with 86% (78 of 91) participating in the DBPCFC at Month 12 of VP 250 treatment.
• The 175 and 91 subjects presented in the OLE cohorts (24 months and 12 months of VP250 treatment, respectively) are a subset of the subjects presented in the EPITOPE 12-month results (e.g., drop-outs, incomplete DBPCFC etc.).
• 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 (ED) ≥1000 mg, or approximately 3 – 4 whole peanut kernels (64.2% in EPITOPE, n=244).
  • 63.8% reached an ED ≥2000 mg (37.0% in EPITOPE, n=244).
  • 55.9% completed the cumulative 3,444 mg DBPCFC without meeting stopping criteria (30.7% in EPITOPE, n=244).
  • Using the EPITOPE primary endpoint definition, 83.9% of subjects were responders (67.0% in EPITOPE, n=244).
• Month-12 assessment of the efficacy parameters in the EPITOPE subjects (n=175) that entered the OLE further demonstrates the improvement in treatment response following an additional 12 months of treatment (24 months total)
  • At month 12, 74.7%, reached an eliciting dose (ED) ≥1000 mg relative to 81.3% at Month 24.
  • At month 12, 52.4% reached an ED ≥2000 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% (17 of 36) 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 (i.e., crossed-over to VP250 and received 12-months of treatment and were thus 2-4 years-old at VP250 treatment initiation): 62.7% reached an ED ≥1000 mg, 36.5% reached an ED ≥2000 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 (after 12 months of active treatment).