Allergy Therapeutics PLC (AIM:AGY, OTC:AGYTF) has cleared an important hurdle in the early testing of its experimental peanut allergy treatment, saying the highest planned dose in its PROTECT study has proved safe and well tolerated.
The phase I/IIa trial has now completed dosing of the minimum required number of participants at that top dose, meeting its primary safety endpoint.
Early findings from 48 volunteers, a mix of peanut-allergic and healthy participants, showed that raising the dose 2,000-fold from the starting level did not trigger safety concerns.
VLP Peanut is designed as a short-course immunotherapy: a treatment that aims to retrain the immune system so that it reacts less aggressively to peanut proteins.
One way researchers track whether these therapies are having an effect is via skin prick tests, where a reduction in wheal size, the small swollen area that forms, can indicate a calming of the allergic response.
Earlier results from lower dose groups showed such reductions, alongside biomarker shifts seen as signs of protection, including suppressed basophil activation and rising levels of protective Ara h2 IgG antibodies.
The company said data from healthy participants also support its proposed mechanism of action.
Preliminary blinded biomarker readings taken three months after the last dose in allergic participants point to a sustained response. A second interim analysis focused on the highest doses is expected in the first quarter of 2026.
The trial is moving into a planned phase of unblinded skin prick tests and longer-term safety tracking, which will continue for up to a year after final dosing. Preparations for a Phase IIb study are underway, with dosing informed by safety and efficacy signals emerging from the current trial.
Manuel Llobet, the chief executive, said: “The PROTECT trial has now reached a key regulatory milestone with the primary safety endpoint achieved at the highest planned treatment dose.
"Safety and tolerability at these dose levels remain supportive, reinforcing our confidence in the short-course approach underpinning VLP Peanut.”
He added that the company’s focus was on using the new data to shape the next stage of development.