Advancement of PRT100 through the Phase 2 clinical program
All clinical studies to date were carried out in Australia under a CTN with the TGA
In a proof of concept Phase 2 double blind placebo controlled randomised trial, 74% of peanut allergic children who received PRT100 developed sustained unresponsiveness to peanut (evaluated by food challenge 2-6 weeks after completing treatment) as compared to 3% of placebo treated patients. The children who developed sustained unresponsiveness to peanut were able to introduce peanut foods freely into their diet (if they chose to) and did not need to avoid peanut. Furthermore, because their peanut allergy had gone into remission, they did not have to continue with regular exposure to peanut to maintain their protection, which many patients were relieved about since they did not like the taste of peanut, a common issue for children with peanut allergy.
Phase 2 trial showed PRT100 is highly effective at inducing sustained unresponsiveness
* Intention to treat analysis
Follow up of children who completed this study showed that 80% of peanut allergic children who had achieved sustained unresponsiveness (remission of their allergy) following 18 months of PRT100 treatment were still eating peanut 4 years later, and 70% (of those who completed a challenge test) had long-term sustained unresponsiveness 4 years after completing treatment.
80% of treatment responders still eating peanut at 4 years post-treatment
A further placebo-controlled Phase 2b study is now underway comparing PRT100 to Oral Immunotherapy (OIT) alone.
Prota is planning a pivotal Phase 3 multinational, multi-centre study to further establish the efficacy and safety of PRT100 in a wider population, with a view to product registration.