Allergy Therapeutics plc (LON: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, has today provided an update on its Grass MATA MPL phase III study, due to start in Autumn 2020.
Following further investigation of the phase III Birch MATA MPL study (B301), the upcoming Grass study will now take a stepwise approach, with two stages covering both the 2020/2021 and 2021/2022 pollen seasons, rather than the single large trial originally planned for the 2020/2021 season.
The study’s stepwise approach has been designed with input from allergy experts. It enables a phase III-scale study to begin in the 2020/2021 season, followed by an interim review to gain insights into the trial, before continuing to the second part of the study.
Results from the Group’s successful G205 phase II clinical study, which completed in 2018, evaluating the dose to be taken into phase III, were recently published in the World Allergy Organisation Journal. The paper “Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing” reports that the immunotherapy demonstrated a highly statistically significant (p<0.0001), monotonic dose response for all pre-specified models, which has enabled the Group to acquire agreement from regulatory authorities in Europe and the USA on a target dose for the phase III clinical programme.
Manuel Llobet, CEO of Allergy Therapeutics, said:
“The planning for our Grass MATA MPL phase III study is now completed and we look forward to starting this important trial.”