Prota Therapeutics Announces Long-Term Study on Peanut Allergy Treatment

Australian clinical-stage biotechnology company, Prota Therapeutics, has announced the publication of a study in the journal Allergy, which compares remission and desensitization endpoints following food allergen oral immunotherapy (OIT). The Phase 2b follow-on study, PPOIT-003LT, reports 2-year post-treatment outcomes for Prota's remission-inducing high-dose peanut oral immunotherapies, PRT120 and PRT100. The study provides significant insights into the long-term outcomes of children who received one of two remission-inducing high-dose peanut oral immunotherapies: a Peanut Oral Immunotherapy on its own (OIT) or a combined Probiotic Peanut Oral Immunotherapy (PPOIT).

Key Takeaways:

• The study reports that participants who achieved remission following treatment were able to stop treatment and safely consume peanuts freely, with no moderate or severe reactions, and no rescue epinephrine injector use.
• At two years after completing treatment, remission participants reported significantly greater improvement in quality of life compared to participants who only achieved desensitization.
• The study found that participants who were only desensitized had difficulty maintaining their required daily peanut ingestion dose and continued to report severe reactions that required rescue epinephrine treatment.
• Both the high-dose OIT (PRT120) and the combination PPOIT (PRT100) treatments provide lasting benefits that persist or are improved upon during the 2-year period after stopping treatment.
• Key findings also confirmed that participants with remission were half as likely to have an allergic reaction to peanut compared with desensitized patients.
• Participants with remission reported substantial and clinically meaningful improvement in health-related quality of life (HRQOL) compared with both desensitized participants and those who remained allergic.

Statistics:

• 86% of eligible children completed the Phase 2b PPOIT-003 randomized trial (151 of 176).
• 51% and 46% of treated patients achieved remission of peanut allergy with PRT120 and PRT100, respectively.
• 15.9% of reactions in the remission group were moderate or severe, compared to 36.8% in the desensitized group.
• 24% of reactions in desensitized participants were moderate or severe.
• 14.3% of desensitized participants required rescue epinephrine to treat reactions.

Sources:

• Allergy journal
• Prota Therapeutics Pty Ltd news release