In exciting news on the immunotherapy front, DBV Technologies announced the completion of their Phase IIb follow-up study of the Viaskin® Peanut treatment for peanut allergy. The two-year study was designed to assess the long-term efficacy and safety of the treatment in subjects that had graduated from their earlier VIPES trial.
The 171 subjects enrolled were previously given 50µg, 100µg, 250µg doses or a placebo via the daily application of a patch on the upper arm or back in the earlier trial. They were scheduled to be given the 50µg, 100µg and 250µg doses in the follow-up study but were all switched to the 250µg dose early on due to a change in the study protocol.
The company press release provided the following statistics regarding the results for the children participants who were administered the 250µg in the original study:
- Treatment benefit was observed to be long-lasting, with 83% (15/18) of children continuing to respond to treatment during the second year of the follow-up study;
- By month-24, a significant proportion of children were tolerating larger doses of peanut compared to the baseline determined at the start of the study;
- Mean and median cumulative reactive dose (CRD) of peanut protein, which measures threshold reactivity during food challenges, progressed to 2,454 mg and 1,440 mg, respectively, at the completion of study; from 1,884 mg and 1,440 mg, respectively, during the month-12 interim assessment; and from 1,068 mg and 444 mg, respectively, at the baseline.
- Several children reached a CRD of at least 5,040 mg of peanut protein at the completion of the study (7/18 patients).
- Peanut-specific immunoglobulin E (IgE) levels were maintained below baseline from year-1 to year-2, and immunoglobulin G4 (IgG4) levels remained high.
- After two years, 14% (3/21) of patients in this cohort discontinued treatment, none reportedly related to Viaskin Peanut.
During the follow-up study, no cases of serious adverse events were reported and no treatment-related administration of epinephrine was necessary.
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 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.