Aqilion receives IND approval
The US Food and Drug Administration (FDA) has approved Aqilion’s IND (investigational new drug) application for the drug candidate AQ280.
The first study in the US aims to verify the pharmacokinetic profile of a new formulation of AQ280 specifically developed for the treatment of patients with EoE (eosinophilic esophagitis).
“It is strategically important for us to continue clinical development with a formulation that is specially adapted for patients who have difficulty swallowing. With a positive response from the FDA, we look forward to completing the final preparations for the start of a Phase 2 study in EoE patients,” says Sarah Fredriksson, CEO of Aqilion.
ARIA-2
The purpose of this study (ARIA-2) is to ensure that the new formulation, a tablet that dissolves in water, has a similar pharmacokinetic profile to the capsule containing the drug candidate used in the Phase 1 study (ARIA-1). The ARIA-2 study is expected to be conducted in June in the US in healthy study participants and the results are expected after the summer.
Aqilion then intends to submit an application to conduct a Phase 2 study in patients diagnosed with EoE in the US, Canada and Europe.
Published: May 12, 2025
