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Aqilion initiates phase 1 clinical trial for chronic inflammatory diseases

The Regulus programme is working to develop a next-generation JAK1 inhibitor for eosinophilic oesophagitis

Clinical development

Aqilion has initiated its ARIA-1 phase 1 clinical safety trial assessing AQ280 – its drug candidate involved in the company’s Regulus development programme – on healthy volunteers.

AQ280 is a super selective Janus kinase 1 (JAK1) small molecule inhibitor that is under development for indications in the chronic inflammatory disease area.

The ARIA-1 trial has 64 healthy volunteers and will investigate potential side effects and pharmacokinetics. The trial is a dose escalation study, with the primary aim of determining the tolerability and safety of the drug candidate. This will be assessed in stages: one group will get a single ascending dose and another group will get a repeated oral dosage over several days as a multiple ascending dose.

The study is being conducted in the UK with the approval of the Medicines and Healthcare Products Regulatory Agency (MHRA) and findings from the ARIA-1 clinical trial are expected to be shared in mid-2023.

Sarah Fredriksson, chief executive officer of Aqilion, said: “Taking the step from preclinical to clinical development is an incredibly important milestone for everyone involved. [We now have] a pipeline with an innovative profile and a clear focus within chronic inflammatory diseases, including programmes from discovery to early clinical development.”

The Regulus programme is focused on developing a next-generation JAK1 inhibitor and Aqilion will start by testing, assessing and developing the drug candidate AQ280 as a potential treatment for eosinophilic oesophagitis (EoE).

EoE is a rare, chronic inflammatory disease of the oesophagus – also known as ‘allergic oesophagitis’ – and its main symptom among patients is swallowing difficulties. EoE is a relatively new diagnosis that is increasing in incidence. The disease is triggered by food allergens and both children and adults can be affected.

Upon completion of the ARIA-1 trial, Aqilion plans to apply for drug testing ahead of the phase 2a study in patients.

Article by
Fleur Jeffries

11th August 2022

From: Research, Healthcare

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