• EAACI Prize recognizes the clinical impact of PRT120 and findings from the PPOIT-003LT study, which showed significant differences between children who achieved remission and those who were only desensitized
• After completing PRT120 therapy, children in remission safely and freely consumed peanuts up to three years after treatment cessation with no requirement for ongoing daily dosing; four- and five-year post-treatment analyses will be presented at an upcoming scientific forum
• Findings underscore the differentiation of PRT120 and its novel short-term dosing regimen from existing approved therapies; a Phase 3 clinical trial evaluating PRT120 is planned to begin next year in the U.S.

Prota Therapeutics Pty Ltd (“Prota”), a clinical-stage biotechnology company focused on the development of novel oral immunotherapy treatments that induce remission of allergy, today announced clinical research conducted in partnership with Murdoch Children’s Research Institute (MCRI) and presented at the 2025 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress was awarded an EAACI Prize for outstanding oral abstract presentation. The presentation reported three-year post-treatment findings from the Phase 2b PPOIT-003 long-term (PPOIT-003LT) study of Prota’s lead candidate, PRT120, a peanut oral immunotherapy with a proprietary short-term dosing regimen designed to induce durable remission.

“These latest long-term data reinforce remission as the preferred treatment outcome,” said Professor Mimi Tang, Ph.D., Director of the Allergy Translation Centre and Head of Allergy Immunology at MCRI, and scientific founder of Prota Therapeutics. “Children in remission after Prota’s unique short-duration oral immunotherapy and dosing regimen, PRT120, not only maintain protection without daily dosing, but also enjoy a better quality of life and freedom from ongoing treatment burden. This work has only been possible through the collaborative efforts of the study teams at MCRI Allergy Immunology, Perth Children’s Hospital, and Adelaide Women’s and Children’s Hospital, and we are deeply grateful to the many families who participated in our trial.”

In the study, at two years after stopping treatment, more than 95% of children who achieved remission were consuming peanuts freely or maintaining regular ingestion (P. Loke, et al, Allergy 2024). At three years post-treatment, the longest follow-up reported to date, more than 90% of remission participants still in the study continued to eat peanuts regularly, with no moderate or severe reactions and no use of rescue epinephrine. Study participants who were desensitized without remission struggled to maintain daily ingestion, were more likely to stop treatment altogether, and continued to report moderate or severe reactions, including some that required epinephrine treatment. These results reinforce remission as the optimal endpoint for patients, provide a strong foundation for the upcoming four- and five-year analyses, and validate Prota’s plans to advance PRT120 into a Phase 3 clinical trial in the U.S., both expected next year.

“This recognition from EAACI underscores the clinical importance of remission as an endpoint,” added Paxton Loke, Ph.D., who presented the data and is a research clinician at MCRI and principal investigator for the PPOIT-003LT. “To see children remain protected and able to eat peanuts freely three years after completing PRT120 treatment, without the anxiety of significant reactions or the demands of indefinite dosing, demonstrates the potential of this approach to transform care for peanut allergy.”

The recognition at EAACI, the leading professional society for allergy and clinical immunology in Europe, affirms the scientific significance of remission as a durable and clinically meaningful endpoint. It follows a 2023 award at the GALEN GA²FA Annual Conference for Prota’s and MCRI’s two-year post-treatment outcomes, marking consecutive international recognition of the program’s long-term data.

“While these awards are not formal measures of clinical success, they do reflect meaningful acknowledgment from leading scientific forums,” Professor Tang added. “Importantly, they provide a strong foundation for our upcoming four- to five-year analyses, which continue to show persistence of remission and sustained improvements in quality of life – rare achievements in the food allergy space.”

Guillaume Pfefer, Ph.D., Director of Prota Therapeutics, concluded, “This recognition not only validates the strength of Prota’s science and clinical research but also adds momentum as we prepare for Phase 3 development of PRT120. With its differentiated dosing regimen and demonstrated durability of effect, PRT120 has the potential to offer children and families the freedom to live without the daily fear and treatment burden of peanut allergy.”

The abstract, titled, “Patterns of peanut ingestion in remission vs. desensitized patients after completion of peanut oral immunotherapy at 3-years post-treatment,” can be found online here.

The study was funded by NHMRC (GNT2017438 and GNT2023962). The content of this communication is the sole responsibility of MCRI and does not reflect the views of the NHMRC.

About PRT120

PRT120 is Prota’s lead candidate and the first oral immunotherapy designed specifically to induce long-lasting remission of peanut allergy. Using a novel, proprietary dosing regimen with a rapid build-up to a high-dose maintenance phase over 18 months, PRT120 induces immune changes that switch off peanut-specific IgE production, the underlying driver of peanut allergy. In a Phase 2b clinical trial, PRT120 achieved best-in-class protection, with nearly 80% of patients tolerating the equivalent of 20–25 peanuts at the end of treatment and was the first therapy to demonstrate sustained protection off-treatment.

About Prota Therapeutics

Prota Therapeutics is a late clinical-stage biotech company dedicated to advancing allergen oral immunotherapies for treating food allergies, particularly addressing the prevalent and potentially life-threatening issue of peanut allergy. Prota was founded to develop and commercialize novel oral immunotherapy treatments and holds an exclusive license to the proprietary food immunotherapy technology developed at the Murdoch Children’s Research Institute. For more, please visit: https://protatherapeutics.com/.

About Murdoch Children’s Research Institute

Murdoch Children's Research Institute is the largest child health research institute in Australia committed to making discoveries and developing treatments to improve child and adolescent health in Australia and around the world. They are pioneering new treatments, trialling better vaccines and improving ways of diagnosing and helping sick babies, children and adolescents. It is one of the only research institutes in Australia to offer genetic testing to find answers for families of children with previously undiagnosed conditions. For more, please visit: https://www.mcri.edu.au/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250916520078/en/

“Children in remission after Prota’s unique short-duration oral immunotherapy and dosing regimen, PRT120, not only maintain protection without daily dosing, but also enjoy a better quality of life and freedom from ongoing treatment burden.”