Earlier this year, a skin patch designed to reduce the risk of anaphylaxis and other severe reactions to peanuts became the first allergy treatment ever granted a Breakthrough Therapy Designation by the FDA.
Earlier this year, a skin patch designed to reduce the risk of anaphylaxis and other severe reactions to s became the first allergy treatment ever granted a Breakthrough Therapy Designation by the US Food and Drug Administration’s (FDA).
The FDA awarded the coveted designation to the Viaskin Peanut treatment after reviewing results from a phase IIb study that found the patch typically increased the amount of peanut protein needed to trigger reactions like anaphylaxis by a factor of 10 or more.
Some study results were presented earlier this year at the annual meeting of the American Academy of Allergy, Asthma and Immunology.
The trial divided 221 patients among placebo and 3 doses of epicutaneous immunotherapy: 50 mcg, 100 mcg, and 250 mcg. Half of the 56 patients who used the 250-mcg patch for a year experienced at least a 10-fold increase in their individual peanut protein eliciting dose (ppED) or ended the trial with a ppED ≥1,000 mg.
Some of the improvement could have been natural. Indeed, 25% of the placebo group met the criteria for a successful response.
That said, the far higher success rates among patients who received the 250 mcg dose were almost certainly not the result of chance (P=0.0108).
The results of the trial were even better for the 113 patients who were children between 6 and 11 years old. Among that particular subgroup, the response rate to the highest dose of medication was 53.6% while the response rate to placebo was 19.4% (P=0.008). Responders, on average, saw a 19-fold increase in peanut-specific immunoglobulin G4.
Lead investigator Hugh Sampson, MD, believes that similar results in a larger phase III trial would likely indicate that epicutaneous immunotherapy will soon produce a transformative improvement in allergy treatment.
“I think the concept, that we can use this low amount of protein in a convenient and safe way, could change the way we do immunotherapy,” said Sampson, the dean of translational biomedical research at Mount Sinai Hospital in New York, where he is also a professor of pediatrics, allergy and immunology.
The patches administer protein directly into the skin, where it activates an immune response without releasing antigens into the blood. Instead, Langerhans cells transport the protein to regional lymph nodes, where they come into contact with T cells that, if all goes well, become desensitized to them.
In theory, the same system should work with many other allergens, which is why the company that makes Viaskin Peanut has already designed Viaskin products targeted at other irritants.
The French biotech company DBV Technologies has already launched a phase I trial of a Viaskin product for milk allergies and has begun preclinical work on a Viaskin product designed to help patients tolerate dust mites.
Those products will take years to reach the market, if they ever reach it, but the FDA’s decision to grant its Breakthrough Therapy designation to Viaskin Peanut could help bring that product to market in the relatively near future.
DBV Technologies is currently preparing to launch a phase III study of the product in children with peanut allergies.
“This Breakthrough designation highlights the urgent need to find a treatment for this life-threatening disease,” said DBV CEO Pierre-Henri Benhamou, MD, “and we are committed to bringing Viaskin Peanut to the market as quickly as possible.”