Allergy immunotherapy company Prota Therapeutics has announced results from a follow up study of the probiotic and peanut immunotherapy (PPOIT) treatment licensed from the Murdoch Childrens Research Institute (MCRI).
According to the company, it shows PPOIT demonstrated long-lasting tolerance effects more than four years after the original study ended.
Prota said it believes the follow up study data provides the strongest evidence yet a cure may be possible for peanut allergy.
Peanut allergy is the most common cause of anaphylaxis, a life-threatening allergic reaction, and one of the most common 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, randomised equally), for 18 months, to assess whether they 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," said the company. "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 follow up study investigated whether the benefits of treatment were maintained four years later.
Professor Tang said the study showed 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,” she 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 per cent) of participants treated with PPOIT in the original trial reported no allergic reactions to either intentional or accidental peanut ingestion in the four years post treatment. Amongst the few that reported allergic reactions to peanut following intentional peanut intake since stopping treatment, none reported anaphylaxis.
Prota Therapeutics, was set up with seed capital from the MCRI and subsequently received Series A funding commitment of $15 million dollars from Australian venture capital firm, OneVentures, with funds leveraged by the Australian government’s Biomedical Translation Fund.
According to Dr Paul Kelly, managing partner of OneVentures, “OneVentures is proud to invest in the translation of Professor Tang’s ground-breaking work into a commercial 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 were extremely promising and, if confirmed in a larger Phase 3 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.”