Allergy Therapeutics PLC (AIM:AGY, OTC:AGYTF) has reported further encouraging results from its ongoing phase I/IIa PROTECT trial, which is testing the safety and tolerability of its short-course peanut allergy vaccine, VLP Peanut.
The company says the candidate was well tolerated in both healthy volunteers and peanut-allergic patients, with no serious safety concerns observed across any dose level.
The vaccine uses a virus-like particle (VLP) to display the major peanut allergen, Ara h2, in a way that reduces its allergenicity while prompting a beneficial immune response.
This approach is designed to train the immune system to tolerate peanut exposure without triggering severe allergic reactions.
Dosing has now been completed in healthy subjects, with no dose-limiting effects reported even at the highest planned levels.
The final dosing cohort, peanut allergic patients receiving multiple escalating doses, is progressing as planned. The study has enrolled 48 participants in total.
Earlier results showed a reduction in allergic responses in treated patients, measured by skin prick tests using whole peanut extract.
The latest data reinforce these findings, showing that VLP Peanut is stimulating the immune system to produce protective antibodies while reducing indicators of allergic reactivity.
Specifically, investigators observed that the vaccine inhibited the binding of IgE antibodies, which play a key role in allergic reactions, to B cells.
There was also a trend towards lower basophil sensitivity and reactivity, particularly at higher doses. These changes were accompanied by increases in IgG antibodies that could offer longer-term immune protection.
The findings will help guide the selection of doses for the upcoming Phase IIb trial, which is due to begin in the second half of 2026. Allergy Therapeutics believes this candidate is currently the most advanced peanut allergy vaccine in development.
Chief executive Manuel Llobet said: “These results signal a major advance in the allergy research community’s search for what remains our holy grail — an effective short-course vaccine for people living with peanut allergy.
"The positive safety profile, together with encouraging early efficacy signals, further strengthens our confidence in the programme and its potential to transform lives.”
The company is positioning VLP Peanut as a potential breakthrough for patients managing one of the most common and dangerous food allergies worldwide.