Allergy immunotherapy company Prota Therapeutics Pty Ltd (Prota) is pleased to announce results from a follow up study of the probiotic and peanut immunotherapy (PPOIT) treatment which it has licensed from the Murdoch Childrens Research Institute (MCRI), demonstrating long-lasting tolerance effects of treatment more than four years after the original study ended.
Prota believes that this followup study data provides the strongest evidence yet that a cure may be possible for peanut allergy and holds important implications for attacking the modern food allergy epidemic. Peanut allergy is the commonest cause of anaphylaxis, a life-threatening allergic reaction, and one of the commonest causes of death from food allergy.
Chief Scientific Officer and lead researcher Professor Mimi Tang, who pioneered the PPOIT treatment, followed children four years after they completed the initial trial. Children in the original PPOIT randomised trial were given either a combination of the probiotic, Lactobacillus rhamnosus, together with peanut protein in increasing amounts, or a placebo (56 children in total, randomized equally), for 18 months, to assess whether children would become tolerant to peanut.
Outstandingly, more than 80 per cent of children who received the combination probiotic peanut oral immunotherapy treatment were able to tolerate peanut at the end of the trial, compared to less than four percent in the placebo group. Children who developed tolerance to peanut in the first trial were instructed to introduce peanut as part of their normal diet after the study ended; whereas children who remained peanut allergic were advised to continue peanut avoidance according to current care.
The latest follow up study investigated whether the benefits of the oral treatment were maintained four years later.
Prof Tang said this study showed that the majority of PPOIT-treated children who tolerated peanut at the end of the original trial were still eating peanut essentially without reactions four years later.
“Of the PPOIT-treated participants who achieved short term tolerance at the end of the original trial, 80% were still eating peanut without symptoms and 70% had long-lasting challenge-proven tolerance four years after stopping treatment,” Prof Tang said.
“These children had been eating peanut freely in their diet without having to follow any particular program of peanut intake in the years after treatment was completed. Over half were consuming moderate to large amounts of peanut on a regular basis, others were only eating peanut infrequently. The importance of this finding is that these children were able to eat peanut like children who don’t have peanut allergy and still maintain their tolerant state, protected against reactions to peanut.”
The majority (83%) of participants treated with PPOITin the original trial reported no allergic reactions to either intentional or accidental peanut ingestion in the four years post treatment. Of critical importance, amongst the few that reported allergic reactions to peanut following intentional peanut intake since stopping treatment, none reported anaphylaxis.
Thisfollow up study was conducted by the MCRI with contributory funding from the MCRI and Australian Food Allergy Foundation. In September 2016, Prota Therapeutics, was set up with seed capital from the MCRI and subsequently received Series A funding commitment of $15 million dollarsfrom Australian venture capital firm, OneVentures, with funds leveraged by the Australian Federal Government’s Biomedical Translation Fund. Prota will accelerate development of an approved product to makethis vital treatment available globally to people with peanut allergy.
Dr Paul Kelly, Managing Partner of OneVentures said:
OneVentures is proud to invest in the translation of Professor Tang’s ground-breaking work into acommercial product for the treatment of peanut allergy in the first instance and then potentially other food allergies. This publication in the Lancet Child and Adolescent Health further validates the quality and rigor of Professor Tang’s work and its potential.
Dr Suzanne Lipe, CEO of Prota Therapeutics, said the results of the investigation, demonstrating such a high proportion of subjects still continuing to be tolerant four years later, was extremely promising and if confirmed in a larger Phase III study, would represent a paradigm shift in the way peanut allergy is managed.
“Rather than using therapy that protects against accidental ingestion, Prota’s products aim to provide sustained long-term effects and the ability to include peanut in the diet. For the first time, we could have products on the market that provide meaningful and long-lasting treatment benefits, which allow sufferers to eat peanut products without thinking about it, as part of a regular diet just like unaffected people.”
“The MCRI and Prota’s success will be a major achievement on a global scale and making this vital treatment available is what drives the team to accelerate the development program through the FDA approval process.”
“It also suggests the exciting possibility that tolerance is a realistic target for other food allergy treatments, opening a potential pipeline of products for the company.”
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