Prota/MCRI Completes Enrolment of Phase 2b Multicentre Clinical Trial of Probiotic Oral Immunotherapy for the Treatment of Peanut Allergy (PPOIT-003)
- Category: Vaccines
- Published on Wednesday, 23 May 2018 13:22
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- 200 patients have been enrolled and commenced on treatment
- The multicentre study is being conducted in Melbourne, Adelaide and Perth
- Treatment will continue through 2019 with top line results expected in the first quarter of 2020
- The randomised, blind study is designed to compare PPOIT (probiotic and peanut oral immunotherapy) with both Peanut OIT (peanut oral immunotherapy without probiotic) and placebo
MELBOURNE, Australia I May 23, 2018 I Pioneering allergy immunotherapy company Prota Therapeutics Pty Ltd (Prota) is pleased to announce full enrolment to the multicentre Phase 2b clinical trial investigating the effectiveness 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 probiotic and peanut oral immunotherapy (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 enrolment at clinical sites in Melbourne, Adelaide and Perth.
Prota CEO, Dr Suzanne Lipe, said of the update: “This is a tremendous milestone in the advancement of PPOIT and another step towards the further validation necessary for commercialisation. The rate of enrolment demonstrates both the demand and necessity for a treatment for peanut allergies, but also other food allergies more generally.”
Previously published in the peer reviewed journal, the Journal of Allergy and Clinical Immunology, children in the PPOIT randomised 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. Impressively, 82 per cent 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 (or 74 per cent with PPOIT compared to three percent with placebo by intent-to-treat analysis). After the study ended, children who developed tolerance to peanut were instructed to introduce peanut as part of their normal diet; whereas children who remained peanut allergic or had only achieved desensitisation were advised to continue peanut avoidance according to current care.
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. The treatment continues to attract the attention of global biopharmaceutical companies, with findings suggesting that tolerance could be a realistic target for treatment of peanut allergy. The possibility that this treatment approach can be applied to treat other food allergies provides additional potential product opportunities for Prota.
Prota Therapeutics has been funded since establishment by OneVentures Funds II and III. “Continuity of funding through the clinical trial process has been critical to ensuring Prota maintains momentum in bringing this life-saving solution to market”, said Dr Graeme Wald, Principal at OneVentures and Chairman of the Prota Board.
Peanut allergy is the most common cause of anaphylaxis, a life-threatening allergic reaction, and a leading cause of death from food allergy.
SOURCE: Prota Therapeutics