Two years of wearing the Viaskin patch for peanut allergy desensitized 81 percent of peanut-allergic children ages 1 to 3, new research finds. That’s up from the 67 percent who were desensitized after one year of patch wearing.
The new data is from an open-label extension of a Phase 3 trial called EPITOPE. That one-year trial involved 362 toddlers, who were randomly assigned to apply either the Viaskin patch, or a placebo patch. The “active” patch contains allergenic protein equivalent to 1/1,000th of a peanut kernel.
Of the group, 266 children enrolled in the open-label extension, which means parents knew their children were using the patch with actual peanut.
During this phase, called EPOPEX, toddlers who had been wearing the active patch continued to wear it for a second year. Those on the placebo were given the option to enroll and try the Viaskin patch as well.
The new data show that, among the 175 who wore the allergy patch for two years, 81 percent of young kids could consume 1,000 milligrams (mg) of peanut before starting to react. That was an improvement on the 67 percent who were able to eat up to 1,000 mg of peanut after wearing the patch for one year. (The amount is the equivalent of 3 to 4 peanuts.)
“We were really thrilled with the results,” says Dr. Pharis Mohideen, chief medical officer for DBV Technologies, which is developing the peanut patch. “If you are on the product and you stay on the product, your results tend to get better over time.”
The company presented the new peanut patch data at the 2023 American College of Allergy, Asthma and Immunology annual meeting in Anaheim.
Improvement on One-Year Results
A higher rate of desensitization with longer patch wearing is not unexpected, says Mohideen. The Viaskin patch is a form of allergy immunotherapy through the skin. Immunotherapy is a treatment that exposes people to small amounts of their allergen in gradually increasing amounts, with the goal of building a patient’s tolerance.
After two years on the Viaskin patch, some toddlers could consume even more peanut. Almost 64 percent could eat 2,000 mg of peanut before starting to react, while 56 percent consumed 3,444 mg of peanut without signs of a reaction. That’s 11 to 13 peanuts, and was highest amount tested.
The extension trial also showed similar effectiveness at one year for the toddlers on placebo who switched to the active Viaskin patch. At one year of patch wearing, 68 percent could consume up to 1,000 mg of peanut before starting to react.
Both studies at one year are “very consistent,” Mohideen says.
Most side effects were local skin reactions at the patch application site, but these decreased during the second year. There were no treatment-related incidents of anaphylaxis among kids during the second year of the patch. One child previously in the placebo group experienced anaphylaxis during the first year of the study. However, it resolved without epinephrine and he continued on the trial.
Peanut Patch’s Next Steps
Previously, the Food and Drug Administration asked the company for additional safety data, to bring the total number of toddlers treated with the Viaskin peanut patch to 600. Mohideen and his team are finalizing that trial protocol and plan to begin enrolling kids for that six-month trial by early Spring 2024.
As of now, there is only one FDA-approved desensitization treatment for peanut allergy, Palforzia. Palforzia is a peanut protein powder oral immunotherapy for children 4 to 17. If approved in the young age group, Viaskin would become the first peanut allergy treatment that didn’t require food consumption.
“Currently, there are no treatment options for the 1-to-3-year-old age range,” Mohideen notes.
The third year of the EPOPEX extension trial in toddlers is continuing as well. That will determine if desensitization continues to improve in the third year of wearing the patch.
DBV Technologies is also preparing to launch a large, Phase 3 double-blind, placebo-controlled trial of a modified peanut patch for use in kids ages 4 to 7.
The patch to be tested in kids in the older age group is slight larger than the one being tested toddlers. The company redesigned the patch in 2020, after the FDA rejected DBV’s application for approval in children ages 4 to 11. At the time, the FDA said it couldn’t approve the Viaskin patch due to concerns with the patch staying adhered to the skin.
The one-year trial in 4-to-7-year-olds, called VITESSE, should begin enrolling in 2024. The company expects to have topline results in the first half of 2025, Mohideen says. The company also needs to do an additional safety study in 4-to-7-year-olds to bring the total number of kids tested to about 600.
Path to FDA Approval
Although there are still a number of steps to go, Mohideen believes they have a regulatory path forward for eventual approval, Mohideen says. The company will likely submit an application for approval in toddlers first.
“We feel like the balance of the efficacy, along with the safety, and the simplicity of use, and the ease of use, overall these things put together, we have a product that can work for a lot of different family lifestyles,” he says. “You put the product on and you go about your daily business.”
Viaskin Patch Photo: DBV Technologies notes that this photo is for illustration only as this product is not yet approved by the FDA.