Aimmune Therapeutics said it has have begun enrolling participants in a European Phase 3 clinical trial of AR101, an oral immunotherapy for desensitizing patients who are suffering from a peanut allergy.
"We are all excited by the momentum in the field and the potential impact a new treatment could have on the burden of peanut allergy, which in many countries affects up to 2 percent of children," George du Toit, professor of pediatric allergy at King's College London, Guy's and St Thomas' Trust, said in an Aimmune release.
The endpoint for the study, expected to involve approximately 160 peanut-allergic children and adolescents, would be a patient being able to tolerate 1,000-milligrams of peanut protein, which translates to between three and four peanut kernels, the release said.
The result will be judged by a double-blind, placebo-controlled food challenge following a nine-month treatment period.
"Desensitization to a threshold of at least 1,000 milligrams of peanut protein would protect peanut-allergic patients from severe reactions following an inadvertent bite of a peanut-containing food," Sue Barrowcliffe, general manager of Aimmune Europe, said in the release. "Achieving high levels of protection quickly and reliably is important to patients."
