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VLP Peanut PROTECT Trial Update
VLP Peanut PROTECT Trial Update.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n\n\n \n \nAllergy Therapeutics plc\n(\"Allergy Therapeutics\", \"ATL\" or the \"Group\")\n \n \nAllergy Therapeutics commences subcutaneous dosing in peanut allergic\npatients in Phase I/IIa VLP Peanut PROTECT Trial\n \n- First patient receives subcutaneous dosing with no safety signals observed\n- Subjects will receive a total of three escalating doses over three separate dosing days\n- This marks the start of the clinical proof of concept phase using biomarkers to assess preliminary efficacy\n- No safety signals observed in the cohorts treated to date\n- In addition, having already demonstrated tolerability of a 25-fold dose increase in 2 cohorts of healthy subjects, dose escalation in healthy subjects has progressed to a third cohort to pave the way for dose escalation to similar strengths in peanut allergic patients\n \n12 March 2024 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces the commencement of subcutaneous dosing of peanut allergic patients in the Phase I/IIa PROTECT trial evaluating its novel virus-like particle (VLP)-based peanut allergy vaccine candidate (\"VLP Peanut\").\n \nPatients allergic to peanuts have previously undergone skin-prick testing in part A of the PROTECT trial. Following an external safety review committee (SRC), it was determined that no safety signals had been observed and it was safe to proceed with incremental subcutaneous dosing in healthy subjects in the Phase I stage and in peanut allergic patients in the Phase IIa part of the trial.\n \nManuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: \"This is a key milestone in our journey to offer transformative outcomes to patients living with peanut allergies. We are excited to begin gathering data supportive of efficacy using biomarker technology which is aligned with recent FDA workshop thinking on demonstrating efficacy in clinical trials. We look forward to the complete results of this trial and continue to work towards the required planning for the phase II.\"\n \nThe PROTECT trial is being conducted in both h...