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.

 

"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.

 

 

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 and it usually debuts at the age of 20-40. 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.

 

The ARIA-1-study

The Phase 1 study was a randomized, double-blind, placebo-controlled study in healthy volunteers conducted in the United Kingdom to assess the safety, tolerability, pharmacokinetics, and food efficacy of AQ280 dosed orally. The study consisted of both single and multiple ascending dose cohorts and included 66 healthy volunteers.

 

The main results from the ARIA-1 study are:

1. Dose: The exposures achieved in the Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts are in line with estimates of a therapeutically effective range based on preclinical models and will inform the dose selection for the upcoming Phase 2 study
2. Safety: No serious adverse events occurred and dose increases in SAD and MAD were not limited by adverse events
3. Pharmacokinetics: The exposure and half-life of AQ280 were consistent with the preclinical predictions and support once daily dosing. Food intake did not significantly affect pharmacokinetics
4. Pharmacodynamics: AQ280 inhibited CXCL10 in a dose-dependent manner. CXCL10 is an established biomarker for JAK inhibition
5. Selectivity: The JAK1 effects were evident and dose-related while no detectable JAK 2 effect on reticoocytes could be detected

 

 

For more information, please contact:
Sarah Fredriksson, CEO, AQILION AB, + 46 (0)70 261 4575, sarah.fredriksson@aqilion.com