“We are pleased to see the results from this pharmacokinetic bridging study. It is an important milestone to have the formulation ready with eosinophilic esophagitis (EoE) patients in focus. Finalizing ARIA-2 now means that we can fully focus on the Phase 2 study. We thank the participants and clinic involved and look forward to advancing AQ280’s clinical development,” says Sarah Fredriksson, CEO of Aqilion.

About the study

The study evaluated the pharmacokinetic profile in healthy participants of a novel, water-dissolvable tablet formulation of AQ280, designed for the treatment of EoE to enable phase 2. The ARIA-2 study was performed as a single-dose randomized, placebo controlled, cross-over study and expanded the dose range compared to the dose range used in Phase 1 (ARIA-1).

“The results clearly showed that the new formulation exhibits a pharmacokinetic profile very similar to the capsule used in the initial ARIA-1 study, with favorable safety and tolerability profile,” describes the company. The study results enable a transition to phase 2 with a formulation that is specifically adapted to patients with swallowing difficulties, the company describes further.

Preparing to initiate Phase 2a and 2b clinical trials

The hallmark of EoE is that patients have serious difficulties in swallowing and often food impaction, and therefore oral therapies need to be designed to facilitate drug intake. Aqilion has developed a formulation that allows EoE patients to take the medication dissolved in water. The primary objective of ARIA-2 was to determine whether the new formulation exhibits a pharmacokinetic profile comparable to the capsule used in the initial Phase 1 study (ARIA-1). The study was conducted in June in healthy participants in the US following an IND approval in May. The ARIA-1 study showed dose dependent changes in biomarkers suggestive of a potent JAK1 inhibitory effect while no detectable JAK 2 effect on reticulocytes was observed. Aqilion is now preparing to initiate Phase 2a and 2b clinical trials in patients diagnosed with EoE across the US, Canada, and Europe.