Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, has announced positive top line results from its exploratory field study (G309) to evaluate the efficacy and safety of Grass MATA MPL, the Group’s short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen. Two short courses of six injections with treatment durations of six and 14 weeks were tested.
– Primary endpoint Combined Symptom Medication Score (CSMS) achieved with clinically relevant improvement across both active treatment groups compared to placebo
– Statistically significant reduction in CSMS seen in both active treatment groups of 29.1% and 36.8% compared to placebo
– Analysis of secondary endpoints including quality of life and biomarkers, consistent with primary endpoint results
– G306 Phase III pivotal trial on track for commencement in H2 2022 in US and Europe
Key results announced today:
· The primary endpoint of the trial, “CSMS averaged over the peak pollen season”, demonstrated a statistically significant difference between active and placebo in both active treatment groups of 29.1% (p=0.0367) and 36.8% (p=0.0088) for the 6 and 14 weeks respectively, indicating a significant reduction in daily symptoms and use of relief medication among participants receiving Grass MATA MPL
· Both dosing regimens were safe and well tolerated
· Changes in allergen specific IgE and allergen specific IgG4 were consistent with the immunological changes expected following allergen specific immunotherapy
· Improvement in rhinoconjunctivitis quality of life questionnaire (RQLQ) was observed in both active treatment groups
· Improvements in the clinical benefits seen in both US and European populations were comparable
The G309 trial was a double-blind, placebo controlled, randomised study over one year and involved 119 patients over 14 sites across Germany and the US. Results from the trial will be used to optimise the study design of the upcoming pivotal Phase III study (G306), due to begin in H2 2022 in the EU and US.
Further analyses of the G309 trial are now underway by the Group and full results, including all secondary and other exploratory endpoints, will be submitted for peer-reviewed publication and presentation at upcoming key conferences.
Manuel Llobet, CEO at Allergy Therapeutics, stated: “We are delighted to announce these results demonstrating a clear treatment effect from our novel, short-course immunotherapy targeting grass pollen allergies. Grass pollen is one of the most common causes of seasonal allergic rhinitis in the Western world. Debilitating symptoms can affect so many aspects of life and new treatment options are needed.
“The Group used a groundbreaking study design that brought state-of-the-art learnings in allergy field trial methodology to examine multiple endpoints and will enable the potential for extensive biomarker analysis. Significantly, the results will enable us to optimally design the upcoming pivotal G306 Phase III field trial, maximising the chances of success and supporting our regulatory plans for entry into the US. I am grateful for the hard work and effort put into this trial by our team at Allergy Therapeutics and everyone across the multiple trial sites, who kept the trial on course despite the challenges faced by the continuing COVID-19 pandemic. I would also like to thank the trial participants, who are vital to our research developing novel, innovative allergy immunotherapies with the potential to transform patients’ lives.”
