Enrollment Complete for Phase 2b Probiotic Oral Immunotherapy Treatment Candidate

Lactobacillus rhamnosus

Immunotherapy company Prota Therapeutics announced it has completed enrollment for a Phase 2b clinical trial of its Probiotic and Peanut Oral Immunotherapy (PPOIT) treatment licensed from the Murdoch Children’s Research Institute (MCRI).

The PPOIT-003 clinical study has been designed to provide evidence of a longer lasting tolerance to peanut in a larger number of patients and to compare PPOIT with peanut oral immunotherapy (OIT) alone, to assess the added effect of the probiotic. Recruitment of participants for the study has been completed ahead of schedule, with enrollment at clinical sites in Melbourne, Adelaide and Perth, Australia.

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Previously published in the Journal of Allergy and Clinical Immunology, children in the PPOIT randomized trial were given a combination of the probiotic, Lactobacillus rhamnosus, together with peanut protein in increasing amounts, or a placebo for an 18-month treatment period. 82% of children who received PPOIT treatment could tolerate peanut at the end of the trial when tested, compared to three percent in the placebo group.

Chief Scientific Officer and lead researcher Professor Mimi Tang, who pioneered the PPOIT treatment, re-evaluated the children four years after they completed the initial trial, to assess long term tolerance. Results published in The Lancet Child and Adolescent Health showed that the benefits of the probiotic peanut oral immunotherapy treatment were maintained four years later in the majority of those treated. “Of those PPOIT-treated participants who were tolerant to peanut at the end of the original trial (and who participated in the follow up study), 80% were still eating peanut and 70% had long-lasting challenge-proven tolerance four years after stopping treatment.”

Unlike many other peanut allergy treatments in development, this therapy allows children with peanut allergy to actively incorporate peanut and peanut products in their regular diet if they wish and does not require ongoing regular treatment to maintain protection.

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