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Allergy Therapeutics completes treatment in G309 field study
6th May 2021 15:34
(Sharecast News) - Commercial biotechnology company Allergy Therapeutics announced the completion of the treatment of all patients in its 'G309' exploratory field study to evaluate the efficacy and safety of Grass MATA MPL in subjects with seasonal allergic rhinitis or rhinoconjunctivitis, induced by grass pollen.
The AIM-traded firm described Grass MATA MPL as a short course, aluminium-free allergen-specific subcutaneous immunotherapy (SCIT) that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.
It said completion of the treatment phase of the study was achieved despite the challenges caused by the ongoing Covid-19 pandemic.
The group executed the dosing phase of the study in such a way that high patient retention was achieved at 97%, without any delay to the scheduled read-out of the data.
It said the G309 double-blind, placebo-controlled, randomised study, performed simultaneously in the United States and the European Union, remained on track to read out in the second half of 2021.
The primary objective of the study was to evaluate the safety and efficacy of a dose of 27,600 SU Grass MATA MPL, previously proven as the optimal efficacious dose in the successful phase 2 dose-finding study, 'G205'.
Allergy Therapeutics said the study was being conducted in patients with grass pollen-induced rhinoconjunctivitis, with the primary endpoint being the combined symptom medication score (CSMS) averaged over the peak grass pollen season.
Results from the G309 study would provide valuable information to optimise the study design of the pivotal phase 3 study, 'G306'.
The G309 study would inform the sample size of the G306 study, which was expected to involve between 900 and 1200 patients over more than 100 trial sites in the EU and the US.
Successful completion of the trial was expected to enable the group to register the Grass MATA MPL product under the Therapy Allergy Ordinance) process in Germany, and should also pave the way for registration via a Biological License Application (BLA) in the US.
"This ground-breaking exploratory trial design has the potential to greatly increase our understanding of allergic rhinitis and how to effectively generate data for product registration via field trials," said chief executive officer Manuel Llobet.
"Challenges brought about by Covid-19 were alleviated by the excellent clinical team here at Allergy Therapeutics and we are very much looking forward to the results later this year.
"The results of the G309 trial will enable us to optimise the design of the pivotal trial G306, which we expect to begin in the second half of 2022."
At 1458 BST, shares in Allergy Therapeutics were up 1.86% at 21.9p.
The AIM-traded firm described Grass MATA MPL as a short course, aluminium-free allergen-specific subcutaneous immunotherapy (SCIT) that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.
It said completion of the treatment phase of the study was achieved despite the challenges caused by the ongoing Covid-19 pandemic.
The group executed the dosing phase of the study in such a way that high patient retention was achieved at 97%, without any delay to the scheduled read-out of the data.
It said the G309 double-blind, placebo-controlled, randomised study, performed simultaneously in the United States and the European Union, remained on track to read out in the second half of 2021.
The primary objective of the study was to evaluate the safety and efficacy of a dose of 27,600 SU Grass MATA MPL, previously proven as the optimal efficacious dose in the successful phase 2 dose-finding study, 'G205'.
Allergy Therapeutics said the study was being conducted in patients with grass pollen-induced rhinoconjunctivitis, with the primary endpoint being the combined symptom medication score (CSMS) averaged over the peak grass pollen season.
Results from the G309 study would provide valuable information to optimise the study design of the pivotal phase 3 study, 'G306'.
The G309 study would inform the sample size of the G306 study, which was expected to involve between 900 and 1200 patients over more than 100 trial sites in the EU and the US.
Successful completion of the trial was expected to enable the group to register the Grass MATA MPL product under the Therapy Allergy Ordinance) process in Germany, and should also pave the way for registration via a Biological License Application (BLA) in the US.
"This ground-breaking exploratory trial design has the potential to greatly increase our understanding of allergic rhinitis and how to effectively generate data for product registration via field trials," said chief executive officer Manuel Llobet.
"Challenges brought about by Covid-19 were alleviated by the excellent clinical team here at Allergy Therapeutics and we are very much looking forward to the results later this year.
"The results of the G309 trial will enable us to optimise the design of the pivotal trial G306, which we expect to begin in the second half of 2022."
At 1458 BST, shares in Allergy Therapeutics were up 1.86% at 21.9p.