Allergy Therapeutics to take 'stepwise approach' to upcoming grass study
Commercial biotechnology company Allergy Therapeutics updated the market on its grass MATA MPL phase 3 study, due to start in autumn 2020, on Tuesday, reporting that following further investigation of the phase 3 birch MATA MPL study, the upcoming grass study would now take a ‘stepwise approach’.
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The AIM-traded firm said two stages, covering both the 2020-2021 and 2021-2022 pollen seasons, would take place, rather than the single large trial originally planned for the 2020-2021 season.
It said that approach had been designed with input from allergy experts, and would enable a phase 3-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 2 clinical study, which completed in 2018, evaluating the dose to be taken into phase 3, were recently published in the World Allergy Organisation Journal, the company noted.
The paper ‘Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing’ reported that the immunotherapy demonstrated a highly statistically significant monotonic dose response for all pre-specified models, which enabled the group to acquire agreement from regulatory authorities in Europe and the United States on a target dose for the phase 3 clinical programme.
“The planning for our grass MATA MPL phase III study is now completed and we look forward to starting this important trial,” said chief executive officer Manuel Llobet.
At 1229 GMT, shares in Allergy Therapeutics were down 0.94% at 10.5p.