Within the Regulus program, Aqilion is developing AQ280, which is a super selective JAK1 inhibitor, as a treatment of the chronic disease eosinophilic esophagitis.
AQ280 is primarily intended for the treatment of eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus. The disease is also known as “allergic esophagitis” and patient experience great difficulty and discomfort swallowing. To date, no drugs with the same mechanism of action have been developed for EoE and there is a high unmet medical need.
A Phase 1 clinical trial of AQ280, ARIA-1, was initiated in August 2022 and is now completed. The study, including 64 healthy volunteers, was conducted to evaluate the safety, tolerability, and pharmacokinetics of the drug candidate AQ280, given in single dose and repeated dosing. Now, data has been collected for all dose groups and the database has been locked for statistical analysis. The preliminary study results, focusing on pharmacokinetics and tolerability, will be presented in Q4, 2023.
Now, Aqilion has started preparations for a clinical phase 2 study in patients, expected to start in 2024.
The Regulus-program was acquired from LEO Pharma in December 2021 (previously LEO 142397, now AQ280).