Allergy Therapeutics PLC (AIM:AGY, OTC:AGYTF) has started screening patients for the second year of its late-stage trial testing a long-acting grass pollen allergy treatment in children.
The study, known as G308, is evaluating the company’s Grass MATA MPL immunotherapy, a treatment designed to desensitise the immune system to grass pollen, a common cause of hay fever.
The trial is the first of its kind to assess both short- and long-term safety and effectiveness of a subcutaneous, or injected, allergy therapy in paediatric patients.
The latest phase will recruit a similar number of participants as the first year, which included 190 children.
Screening and randomisation are expected to finish by early 2026, allowing all injections to be given before the start of the next grass pollen season.
Short-term safety data from the first year are due in the final quarter of 2025, with results on short-term efficacy expected in late 2026.
Children who continue in the long-term phase will receive either active treatment or placebo for three additional years, followed by two years of observation without treatment.
The trial’s design also improves on typical regulatory study models by limiting the proportion of patients receiving long-term placebo treatment to roughly 8–13%, compared with the usual 50%, allowing most participants to receive the active therapy.
Manuel Llobet, chief executive of Allergy Therapeutics, said: “The commencement of screening in the second year of our phase III G308 trial builds upon our commitment to addressing the unmet needs of the paediatric population in grass allergy.
"Overall, we have invested over $100 million in clinical development in grass allergy to date and combined with our successful adult trials, this long-term trial will help us in our aim to provide children affected by grass allergies with an alternative treatment journey that is less burdensome compared to taking tablets daily.”
Allergy Therapeutics, which is listed on London’s AIM market, has been developing a range of allergy immunotherapies aimed at reducing reliance on daily medication and offering more durable relief from seasonal allergic rhinitis.