The dose-setting trial for the vaccine, GrassMATAMPL, will involve 250 patients with headline data expected at the end of the first half of 2016. The results of that should lead on to a US Phase III study.
Allergy said the product design allows for an effective cumulative dose to be attained in up to six weeks, avoiding the continuous administration required by conventional subcutaneous injectable treatments.
For the first time, the dosing study will use two mobile environmental exposure chambers.
Based in Cincinnati and in New Jersey Shore, the chambers are inflatable laboratories that enable subjects to be exposed to a constant concentration of pollen for periods of three hours over four consecutive days. These labs will allow the study to be conducted outside of the grass pollen season.
Tim Higenbottam, Allergy‘s R&D director said the trial was on schedule and would prepare the ground for entry into the high value US market.
“GrassMATAMPL has the potential to become the best in class ultra-short course SCIT [injectable] in the US market”