Allergy Therapeutics PLC (AIM:AGY, OTC:AGYTF) has reached a key milestone in the clinical development of its peanut allergy vaccine with healthy volunteers now receiving the highest planned doses and no safety issues reported.
The AIM-listed biotech said on Thursday that the final phase of its Phase I/IIa PROTECT trial is underway, with its vaccine candidate, known as VLP Peanut, being tested at doses beyond the expected therapeutic range. The aim is to establish a strong safety margin before moving into a larger Phase IIb study.
At the same time, peanut-allergic patients in the trial are also progressing through higher dose levels. The third of four planned patient cohorts has now completed the first stage of dose escalation and is advancing through the next round after a positive safety review.
Both sets of data - from healthy volunteers and allergic patients - will help determine the optimal dosing for future studies.
The news comes as Allergy Therapeutics also announced the publication of a peer-reviewed paper in the Journal of Allergy and Clinical Immunology, which supports the proposed mechanism of action behind VLP Peanut.
The research shows that the vaccine may reduce allergic responses while boosting protective immune activity in cells from peanut-allergic individuals. Early skin testing in six adults also confirmed the candidate was safe and well-tolerated.
Professor Mohamed Shamji, Professor of Immunology and Allergy at Imperial College London and senior author of the paper, said: "There remains an urgent and compelling need for a therapy that not only ensures sustained protection during extended treatment-free periods but also holds the promise of curing peanut allergies."
Peanut allergy remains a significant unmet need, especially in the US and Europe, where effective treatments are limited. Allergy Therapeutics expects to report initial topline data from the ongoing trial this summer.