Allergy Therapeutics PLC (AIM:AGY, OTC:AGYTF), the UK biotechnology company specialising in allergy immunotherapies, has published three new studies in the journal Allergy that strengthen the evidence for its investigational grass pollen allergy treatment, Grass MATA MPL.
The papers focus on the treatment's use in combating allergic rhinoconjunctivitis, a condition involving both nasal and eye symptoms triggered by grass pollen.
Grass MATA MPL is an aluminium-free injection, given as a short course of six doses before the start of the grass pollen season.
The treatment is currently under review for approval in Germany, with a possible commercial launch next year if approved.
The studies, which include a meta-analysis and a survey of patients, confirm that the short-course jab met the main goals in clinical trials.
In a phase III trial known as G306, published by Zielen and colleagues, the treatment was found to reduce the combined symptom and medication score, a measure used in allergy trials, by 20.3% compared to a placebo during peak pollen season.
The results were described as “highly statistically significant,” with a p-value of 0.0005.
A further meta-analysis, combining results from two phase III trials (G306 and G309) and involving 674 adults, showed an improvement of 22.5% over placebo on the same measure. This was also statistically significant, with a p-value of 0.00004.
One of the new papers also provides context for what patients consider a meaningful improvement.
According to a survey of 1,071 people with grass allergies, nearly 70% regarded a one-point improvement in their most severe allergy symptom as clinically relevant.
Using patient feedback and established quality-of-life questionnaires, researchers concluded that a 16% reduction in the main symptom score is the minimum level considered significant by those affected.
The results were described by Allergy Therapeutics as completing the publication cycle for the adult phase of Grass MATA MPL’s clinical development.
A separate long-term study for children with grass pollen allergies is ongoing, with the first group of paediatric patients now having completed their initial grass pollen season.