Patch effective through 36 months in treating toddlers with peanut allergy
Key takeaways:
- The VIASKIN Peanut patch includes 250 µg of peanut allergen extract.
- Adverse event rates decreased through 3 years.
- Patients who wore the patch for 20 hours or more each day had better outcomes.
Two-thirds of toddlers with peanut allergy who used the VIASKIN Peanut patch from DBV Technologies completed an oral food challenge at 36 months without meeting criteria for stopping, according to a webinar held by the company.
“The VIASKIN Peanut patch is designed to be a very patient-centric product that is intended to be extremely easy and simple to use,” Pharis Mohideen, MD, MS, chief medical officer at DBV Technologies, told Healio.
The delivery system
The open-label extension of the phase 3 EPITOPE trial included children aged 1 to 3 years with peanut allergy who used the VIASKIN Peanut patch, which includes 250 µg of peanut allergen extract, or about one-thousandth of a peanut kernel.
Caregivers applied a fresh patch to the lower area of the child’s back each day.
“It takes only a few seconds to apply, and that’s it,” Mohideen said. “That patient then goes about their daily lives with no restrictions on activities.”
Langerhans cells in the skin uptake the allergen via water loss and solubilization. The patch does not have any analogs in other peanut allergy therapies, the company said.
“That’s how our phase 3 studies were designed and conducted,” Mohideen said.
Generally, patients use allergen immunotherapies for years to achieve an optimal response, he added.
“VIASKIN Peanut, with its ease of use and very good tolerability, retained a very high percentage of subjects — 85% over this 3-year period,” Mohideen said. “This is how we expect the product may be used, if approved.”
As an investigational product, Mohideen noted, the VIASKIN Peanut patch has not been approved by the FDA or any other regulatory authority yet. Also, the patch does not require any oral intake of peanut, nor does it require any injections.
“So, our epicutaneous mode of delivery is also very unique,” Mohideen said.
Study results
During double-blind placebo-controlled food challenges (DBPCFC), percentages of children who achieved an eliciting dose of 1,000 mg or more of peanut, or the equivalent of three or four peanuts, included 64.2% at 12 months (n = 244), 81.3% at 24 months (n = 160) and 83.5% (n = 139) at 36 months.
Similarly, percentages of children who achieved an eliciting dose of 2,000 mg or more of peanut, or the equivalent of six to eight peanuts, during DBPCFCs included 37% (n = 244) at 12 months, 63.8% (n = 152) at 24 months and 72.7% (n = 132) at 36 months.
Percentages of children who completed DBPCFCs without meeting stopping criteria, with a cumulative dose of 3,444 mg or the equivalent of 12 to 14 peanuts, included 30.7% (n = 244) at 12 months, 55.9% (n = 152) at 24 months and 68.2% (n = 132) at 36 months.
The researchers noted that the median dose of peanut protein consumed during accidental consumption is 125 mg.
“The median entry eliciting dose was 100 mg, and after 3 years of VIASKIN Peanut treatment, subjects went from an eliciting dose of about one-third of a peanut kernel to 12 to 14 peanut kernels without meeting stopping criteria for the food challenge,” Mohideen said. “That is a tremendous amount of protection against an accidental peanut consumption.”
Percentages of patients who experienced treatment-related treatment-emergent adverse events included 100% (n = 175) at year 1, 92% (n = 161) at year 2 and 68.5% (n = 113) at year 3. There was only one treatment-related serious treatment-emergent adverse event, which occurred during year 1, and one treatment-emergent adverse event leading to discontinuation, which occurred during year 2.
Percentages of patients who experienced treatment-related local treatment-emergent adverse events included 100% (n = 175) in year 1, 92% (n = 161) in year 2 and 67.3% (n = 111) in year 3. Prevalence of severe treatment-related local treatment-emergent adverse events included 21.1% (n = 37) in year 1, 5.7% (n = 10) in year 2 and 1.8% (n = 3) in year 3.
Treatment-emergent local adverse events of special interest prevalence included 22.9% (n = 40) in year 1, 14.9% (n = 26) in year 2 and 8.5% (n = 14) in year 3.
Three children had a treatment-related anaphylactic reaction, and two had a treatment-related treatment-emergent adverse event leading to epinephrine use, all during year 1.
“There were no treatment-related anaphylactic events in either the second or third years of treatment, with clinical benefit continuing to improve,” Mohideen said.
Additionally, 68.4% of the children consistently achieved an average daily wear-time (ADWT) of 20 hours or more, with a median of 22.9 hours. Other medians included 16.7 hours for those who did not achieve an ADWT of 20 hours or more and 23.7 hours for those who used placebo.
The children with less than 20 hours of ADWT reported more scratching that resulted in the patch getting detached from their bodies, which indicated lower tolerability or greater degree of itch in local peanut-induced skin immune response, the researchers said.
The researchers noted that ADWT within the first 90 days of use was highly predictive of ADWT over a 12-month period (r = 0.81). Percentages of children with efficacy over 12 months included 75.7% of those with an ADWT of 20 hours or more during the first 90 days and 47.3% for those with an ADWT of less than 20 hours (P < .01).
Further, 71.9% of children with an ADWT of 20 or more hours and 42.9% of those with an ADWT of less than 20 hours reached an eliciting dose of 1,000 mg or higher (P < .01). Similarly, 40.1% of those with an ADWT of 20 or more hours and 28.6% of those with an ADWT of less than 20 hours achieved an eliciting dose of 2,000 mg.
Overall clinical responses, the researchers noted, included 67% for children on active therapy and 33.5% for those on placebo.
Other findings comparing children with an ADWT of 20 or more hours with those with less than 20 hours included treatment-based epinephrine use (0.6% vs 2.6%), anaphylaxis (0.6% vs 3.9%) and permanent discontinuation (9.6% vs 19.5%).
Mohideen noted that the safety profile among patients who used the VIASKIN Peanut patch in this study was consistent with the safety profile of children aged 4 to 11 years in other studies who also used it, which he called very reassuring since toddlers may be seen as a more vulnerable patient population.
“The data in more than 1,600 subjects and more than 1 million patches applied daily during clinical trials demonstrate a safe and well tolerated product,” he said.
Peanut protein is not readily measurable in systemic circulation in animal studies, he continued.
“We believe this translates clinically into the safety profile observed in our studies,” Mohideen said.
Conclusions, next steps
“The 3-year data further supporting the efficacy associated with VIASKIN Peanut are robust,” Mohideen said. “In many ways, we believe these longer-term data demonstrate a benefit-risk not previously observed with other treatment options.”
Also, Mohideen said, the data build on the efficacy associated with epicutaneous immunotherapy.
“As is the case with other modes of delivery for allergen immunotherapy, such as subcutaneous immunotherapy, optimal treatment effect usually takes several years,” he said. “This is what we are seeing with VIASKIN Peanut, which is not at all surprising.”
DBV Technologies believes that it is now fully aligned with the FDA on its biologics license application (BLA) paths for both toddlers and children and has agreed with the FDA on an accelerated approval pathway for the toddler indication.
The FDA has asked the company to conduct supplemental safety studies, with one study for toddlers and one for children, to reach total exposures in close to 600 subjects for at least 6 months. Each indication will then have its own safety study.
“The FDA was not asking us to assess any specific safety signal,” Mohideen said. “Their request is just following the regulatory guidelines for treatment exposure numbers.”
DBV Technologies expects to start both studies in the second quarter of this year and plans on submitting its BLAs in the second half of the year.
Reference:
- DBV Technologies announces positive 3-year results from EPITOPE Phase 3 open-label extension study. https://dbv-technologies.com/press_releases/dbv-technologies-announces-positive-3-year-results-from-epitope-phase-3-open-label-extension-study/. Published Jan. 8, 2025. Accessed Jan. 10, 2025.