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 randomized controlled study comparing PRT100 to placebo in 1- 10 year old children with peanut allergy, 74% *(ITT analysis) of children who received PRT100 achieved the primary outcome of sustained unresponsiveness to peanut compared with 3% of children who received placebo. Follow up of these children 4 years after treatment was completed showed that the majority of treatment responders were still eating peanut.
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 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 currently underway comparing PRT100 to Oral Immunotherapy (OIT) alone.
Prota is also planning a pivotal Phase 3 multinational, multi-center study to be conducted under an Investigational New Drug Application to further evaluate the efficacy and safety of PRT100 in a wider population, with a view to product registration.