DBV Technologies

Topline Results from Two-Year Follow-Up Study of Viaskin Peanut Show Long-Lasting and High Levels of Desensitization to Peanut - Seite 2

Despite treatment with suboptimal dose regimens, children treated with Viaskin Peanut 50 micrograms or 100 micrograms in VIPES, who later received the 250 micrograms dose during OLFUS, showed increased levels of desensitization at month-24. Additional exploratory observations include the following:

• A majority of children receiving suboptimal dose regimens responded to treatment by the completion of OLFUS.
• Patients generally increased oral peanut intake over time in a dose-dependent manner.
• Patients initially treated with the lowest dose were more likely to discontinue therapy and were also less likely to achieve the highest CRD levels at month-24.
  
  

Preliminary analysis on sustained benefit following treatment discontinuation:

All subjects who were unresponsive to a cumulative reactive dose of above 1,440 mg of peanut protein at the month-24 DBPCFC in OLFUS were eligible to continue the study for two additional months. During this period, patients did not receive treatment and were required to maintain a peanut-free diet. In an exploratory analysis, all of the 19 children who completed the DBPCFC at month-26 reached a CRD of at least 1,440 mg, showing a meaningful durability of response in the absence of treatment.

Complete results from the OLFUS study will be submitted for presentation at a future medical meeting.

"We would like to thank the patients, caregivers, and clinicians who devoted their time to complete this long trial," said Dr. Hugh Sampson, Chief Scientific Officer of DBV Technologies, Director of the Jaffe Food Allergy Institute at Mount Sinai, and Co-Principal Investigator of the OLFUS-VIPES study. "These three years of epicutaneous immunotherapy data seem to support DBV's innovative and proprietary approach of desensitizing food allergic-patients through the skin in order to minimize safety concerns associated with allergen exposure. We are also excited to see durable responses in the absence of treatment and no peanut consumption, although additional analyses will need to be performed to better understand these findings. These results suggest that the immunomodulatory changes observed in patients treated with Viaskin may be more sustained."