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Successful primary outcome of VLP Peanut 001
Successful primary outcome of VLP Peanut 001.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 3254H\n Allergy Therapeutics PLC\n 03 August 2021\n \n \n \n \n \n \n \n Allergy Therapeutics plc\n \n \n (\"Allergy Therapeutics\", \"ATL\" or the \"Group\")\n \n \n \n \n \n \n \n \n Allergy Therapeutics announces successful primary outcome of VLP Peanut 001; a study evaluating biomarkers from peanut allergic patients\n \n \n \n \n \n - Study results confirm peanut vaccine candidate's hypoallergic potential\n \n \n - Findings support VLP Peanut first in-human Phase I study design, on track to start Q1 2022\n \n \n - Short-course peanut allergy vaccine candidate represents a significant opportunity in $8 billion worldwide food allergy market\n \n \n - Results strengthen Phase I study IND application being submitted to US FDA in late 2021\n \n \n \n \n \n \n 03 August 2021 \n \n Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology pharmaceutical company specialising in allergy vaccines, today announces positive primary results from an ex-vivo biomarker study evaluating the Group's novel virus-like particle (VLP) based peanut allergy vaccine candidate (\"VLP Peanut\"). \n \n \n \n \n \n The study, which took place at Imperial College London, evaluated the Group's short-course VLP Peanut and aimed to demonstrate the vaccine candidate's hypoallergic potential. If a vaccine is hypoallergenic, it means it does not illicit an allergic reaction in patients upon dosing. The study used blood samples from peanut allergy patients to evaluate an extensive set of functional and molecular biomarkers. This resulted in a successful primary outcome, with the trial demonstrating a significant 24-fold reduction in basophil activation and histamine release after blood samples were challenged with VLP Peanut compared to a recombinant peanut extract, signifying the hypoallergenic potential of the vaccine candidate. These positive clinical data add to the Group's strong pre-clinical research package, which has demonstrated sustained immunologic protection following peanut exposure after just one single vaccination. \n \n \n \n \n \n The biomarker study results are encouraging and provide strong support for the human translation of the pre-clinical results and strong confidence in the data to be generated in the planned Phase I stu...