Prota Therapeutics has announced the publication of a long-term study in the journal Allergy, confirming the clinical benefits of achieving remission in peanut allergy through oral immunotherapy (OIT). The Phase 2b follow-on study (PPOIT-003LT) assessed two-year post-treatment outcomes of Prota's high-dose peanut oral immunotherapies, PRT120 (standalone OIT) and PRT100 (probiotic OIT combination), which previously induced remission in 51% and 46% of patients, respectively.
Long-Term Outcomes of Remission-Inducing Therapies
The PPOIT-003LT study, a continuation of the Phase 2b PPOIT-003 trial, compared long-term outcomes in children who received either PRT120 or PRT100. The study focused on comparing the benefits and risks associated with remission, desensitization, and persistent allergy, while also reporting long-term outcomes compared to placebo.
The findings indicated that remission is a more favorable outcome than desensitization. Participants in remission were able to discontinue treatment and safely consume peanuts. Two years post-treatment, this group reported fewer peanut ingestion reactions, with no moderate or severe reactions, and no need for rescue epinephrine. Crucially, they experienced significantly greater improvements in their health-related quality of life compared to those who only achieved desensitization.
In contrast, participants who only achieved desensitization struggled to maintain their required daily peanut ingestion dose and continued to report severe reactions requiring epinephrine. This group did not experience any improvement in quality of life compared to the allergic group.
Sustained Benefits of PRT120 and PRT100
The study confirmed that both PRT120 and PRT100 provide lasting benefits that persist or improve during the two-year post-treatment period. Children experienced fewer reactions over time and continued to exhibit significantly improved health-related quality of life (HRQOL) compared to the placebo group.
Key findings from the study include:
- High-dose peanut OIT (PRT120) and probiotic-combined high-dose peanut OIT (PRT100) led to lasting benefits two years post-treatment, including improved quality of life compared to placebo.
- Participants with remission were half as likely to have an allergic reaction to peanut compared with desensitized patients (15.9% vs. 36.8%).
- In the second year post-treatment, remission participants had no moderate or severe reactions and did not require rescue epinephrine.
- Remission participants reported substantial and clinically meaningful improvement in health-related quality of life (HRQOL) compared with both desensitized participants and those who remained allergic.
Study Design and Patient Population
The study involved 151 children aged 1-10 with confirmed peanut allergy who had completed the Phase 2b PPOIT-003 randomized trial. The study endpoints included a comparison of long-term outcomes by clinical allergy status (remission, desensitization, persistent allergy) and by treatment group (PRT120, PRT100, placebo). Outcomes measured included peanut ingestion, reactions, and health-related quality of life (HRQOL) at one and two years post-treatment.
Expert Commentary
According to Principal Investigator Dr. Paxton Loke from the Murdoch Children's Research Institute (MCRI), "Remission offers a more favorable long-term outcome in terms of reduced reactions and improved quality of life compared to desensitization without remission or persistent allergy. This study underscores the need to aim for remission as the optimal clinical outcome."
Professor Mimi Tang, Director of the Allergy Translation Centre, Head of Allergy Immunology at MCRI, and CEO of Prota Therapeutics, added, "The findings from the PPOIT-003LT study highlight the significant benefits of achieving remission through PRT120 treatment, a high-dose rapid escalation oral immunotherapy for peanut allergies."
