Data show clinical remission of peanut allergy in children treated with new immunotherapy

Investigators found that 51% of participants achieved sustained peanut insensitivity after 18 months of treatment.

New results from a Phase 2b clinical trial show that pediatric patients with peanut allergy achieved clinical remission after receiving PRT120, an investigational oral immunotherapy with a novel high-dose, rapidly escalating dosing regimen.

The results of the placebo-controlled trial confirm the efficacy of PRT120 in inducing clinical remission of peanut allergy in children and improved quality of life in patients. The trial was designed to analyze the effect of oral immunotherapy delivered via a proprietary high-dose, rapid-escalation regimen, compared to oral immunotherapy similarly delivered with a probiotic.

“It is an exciting time for our company with the release of these remarkable results,” said Mimi Tang, PhD, FRACP, FAAAAI, CEO of Prota Therapeutics, in the press release. “This is the first randomized controlled study of oral peanut immunotherapy to show high rates of sustained non-response in school-aged children and the first to show high rates of sustained non-response in school-aged children, and the first to show that treatment for peanut allergy can provide a substantial improvement in quality of life compared to current standard peanut avoidance care.

The trial was conducted at Royal Children’s Hospital Melbourne, Perth Children’s Hospital and Women’s and Children’s Hospital Adelaide, Australia. It involved 201 children between the ages of 1 and 10, and the trial was run over 4 years with participants followed for up to 12 months after treatment.

In the press release, the researchers noted that rates of peanut allergy are increasing, calling for improved treatments. About 1.1 million patients between the ages of 1 and 17 were diagnosed in the United States alone in 2021, according to researchers.

Investigators found that 51% of participants achieved sustained peanut insensitivity after 18 months of treatment. This step allowed patients to completely stop treatment and freely eat peanuts safely, according to the study.

It is important to note that allergic remission refers to the absence of clinical reactivity which persists after discontinuation of treatment for a period of time. This is different from desensitization, which is a temporary increase in the amount of allergens that causes a reaction in patients that is only maintained with continued treatment. Allergen desensitization provides protection against accidental exposure to allergens, but patients must continue daily treatment and maintain strict allergen avoidance.

Previous studies of oral peanut immunotherapy have shown limited success in stimulating remission, with only a small subset of participants achieving this endpoint after years of treatment. In the new trial, 51% of children achieved remission after 18 months, compared with 5% in the placebo group. This is the highest remission rate ever reported for stand-alone oral peanut immunotherapy treatment in school-aged children.

REFERENCE

Prota Therapeutics Reaches a Milestone in the Treatment of Peanut Allergy: Groundbreaking Clinical Trial Data Demonstrates Clinical Remission of Peanut Allergy in Pediatric Patients. Press release. Prota Therapeutics; February 9, 2022. Accessed May 18, 2022. https://protatherapeutics.com/wp-content/uploads/2022/02/Press-Release_-Prota-Therapeutic_9-Feb-22.pdf

Irene B. Bowles