Allergy Therapeutics plc (LON:AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announced highly positive top-line results from its Grass Modified Allergen Tyrosine Absorbed (MATA) MPL Phase II dose ranging study (G205). The trial met its primary endpoint of establishing a dose-response relationship and a Phase III dose. Approximately 30% of the population in Europe and 25% of the population of the US are allergic to grass pollen1, one of the most prevalent global aeroallergens.
The key results announced today:
· Primary endpoint of the trial met with highly statistically significant dose-response relationship (p<0.0001)
· All dosing regimens were safe and well tolerated
· The currently marketed product showed a significant improvement compared to placebo (p<0.01)
· Significant increase in immunoglobulin results, highly consistent with the dose response observed for the primary endpoint
· Adherence to the short treatment course was excellent. More than 95% of patients received the target cumulative dose during six weekly subcutaneous injections
The G205 trial is a multi-centre, double-blind, placebo controlled study designed to explore the safety and response of different cumulative doses of Grass MATA and MPL for grass-pollen induced seasonal allergic rhinitis. The European study took place in Germany, Poland and Austria and 447 patients were randomised into four active arms plus a placebo, evaluating the change in allergic symptoms as determined by the total symptom score (TSS) following conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.
Manuel Llobet, CEO at Allergy Therapeutics Plc, stated: “We are thrilled with these extremely positive results demonstrating dose dependent efficacy of the product including the current marketed dose. This study represents a major milestone in our path forward to a registered grass allergy product in Europe. Additionally, this brings us closer towards marketing authorisation in the estimated $2bn US allergy market, a significant opportunity where our product has the potential to be the first registered subcutaneous immunotherapy for the treatment of grass allergy. With an optimal dose identified, we look forward to sharing this new, exciting data with the health authorities and plan to commence a Phase III study in 2019.
“Allergy Therapeutics provides the only ultra-short course, aluminium-free treatment containing our MPL adjuvant in the European market, and its convenience for patients is driving market penetration in all our markets.”