Aqilion has completed Phase 1 study with AQ280 within the Regulus program
AQILION (publ) announces today that it has successfully completed the first clinical study in humans within the Regulus program. The Phase 1 ARIA-1 study was conducted to evaluate the safety, tolerability, and pharmacokinetics of the drug candidate AQ280 in healthy adult participants, given in single dose and repeated dosing. The preliminary study results are expected in Q4 2023.
Within the Regulus program, Aqilion is developing AQ280, which is a super selective JAK1 inhibitor, as a treatment of the chronic disease eosinophilic esophagitis. Since August last year, healthy volunteers have been administered single or multiple doses in sequential escalating dose groups until the maximum planned dose of AQ280 was reached. Data describing the pharmacokinetic profile, safety and tolerability of the drug candidate was evaluated between every dose escalation. 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.
“We have reached an important milestone for Aqilion and the Regulus program. Now, we can begin preparations for a clinical phase 2 study in patients expected to start in 2024. Our goal is that the results of the Phase 1 study will bring us closer to a new effective treatment for patients with eosinophilic esophagitis”, says Sarah Fredriksson, CEO of Aqilion.
About the AQ280
AQ280 is an oral, small-molecule, super selective JAK1 inhibitor. JAK1 is an enzyme, a kinase, that accelerates inflammatory processes, which, among other things effects allergy and fibrosis. By inhibiting its mechanism, it is possible to reduce symptoms and disease development in chronic inflammatory diseases.
About Eosinofil Esophagatis
Eosinophilic Esophagitis is an allergic disease of the esophagus. The main symptom of this chronic disease is significant difficulty swallowing, and the disease can lead to scar tissue development and strictures of the esophagus causing food to get stuck or impact the esophagus. The disease can occur in patients of any age but tends to be more common in younger adults. There is a clear medical need for new therapies as the number of patients diagnosed is rapidly increasing and the knowledge and awareness of the disease becomes more widespread. Currently, two different types of drugs have been approved: treatment with corticosteroids is approved in Europe and treatment with a biologic drug, an anti-IL4/13 antibody, is approved in the US and in Europe. There is currently no approved treatment of eosinophilic esophagitis with the same mechanism of action as Aqilion’s drug candidate AQ280.