Prota Therapeutics Publishes Study on Long-Term Peanut Allergy Remission

Prota Therapeutics, an Australian clinical-stage biotechnology company, has announced groundbreaking findings from a long-term study on peanut allergy treatments. The research, published in the journal Allergy, underscores the significant long-term benefits of Prota's high-dose oral immunotherapy treatments designed to induce remission of peanut allergies. The study, known as PPOIT-003LT, is a continuation of the Phase 2b PPOIT-003 randomized, multi-center trial and highlights the advantages of aiming for remission over mere desensitization.

The PPOIT-003LT study focused on children who received either a standalone high-dose Peanut Oral Immunotherapy (OIT) or a combined Probiotic Peanut Oral Immunotherapy (PPOIT). The primary goal was to compare the long-term outcomes of these treatments in terms of remission, desensitization, and sustained allergy, and to examine the differences in health-related quality of life (HRQOL) among these groups.

Key findings from the study reveal that remission, defined as the ability to stop treatment and safely consume peanuts without significant adverse reactions, offers substantial and lasting benefits. Participants who achieved remission reported significantly fewer peanut ingestion reactions, with no moderate or severe reactions, and did not need to use rescue epinephrine injectors. Most importantly, these participants experienced a marked improvement in their quality of life compared to those who only achieved desensitization.

In contrast, participants who were merely desensitized struggled to maintain their required daily peanut ingestion dose and continued to experience severe reactions that necessitated rescue epinephrine treatment. Their quality of life did not show any notable improvement compared to those who remained allergic.

The study also confirmed that both high-dose OIT (PRT120) and the combination PPOIT (PRT100) treatments provide enduring benefits. Two years after completing treatment, children continued to experience fewer allergic reactions and reported significant improvements in their quality of life compared to those who received a placebo.

Among the standout statistics, remission participants were half as likely to have an allergic reaction to peanuts compared to desensitized participants (15.9% vs. 36.8%). Additionally, in the second year post-treatment, remission participants had no moderate or severe reactions and did not require rescue epinephrine, whereas 24% of the reactions in desensitized participants were moderate or severe, with 14.3% needing rescue epinephrine.

The study involved 151 children aged 1-10 with confirmed peanut allergies who completed the Phase 2b PPOIT-003 trial. The research compared long-term outcomes based on clinical allergy status and treatment group, measuring factors like peanut ingestion reactions and HRQOL at one and two years post-treatment.

The PPOIT-003LT study's conclusions emphasize that achieving remission is a more favorable outcome than desensitization. Remission led to fewer and milder allergic reactions, no need for rescue epinephrine, and significantly better quality of life. These benefits persisted or even improved over time, highlighting the lasting impact of Prota's treatments.

Prota Therapeutics, established in 2016, aims to develop and commercialize novel oral immunotherapy treatments for food allergies, particularly peanut allergies. The company holds an exclusive license to proprietary food immunotherapy technology developed at the Murdoch Children's Research Institute (MCRI).

Murdoch Children's Research Institute, the largest child health research institute in Australia, is dedicated to improving child and adolescent health through pioneering treatments, better vaccines, and advanced diagnostic methods.