The company’s Phase 1 clinical safety study on the drug candidate AQ280 on healthy volunteers has started.
The substance AQ280, part of the company’s Regulus development program, is a super selective JAK1 small molecule inhibitor that is under development for indications within chronic inflammatory diseases. Aqilion has thus reached a very important milestone as the company has managed to take the big step from preclinical phase to clinical Phase 1, it states.
“Our first Phase 1 clinical trial has begun, which means that Aqilion is now a biopharmaceutical company that engages in clinical development. Taking the step from preclinical to clinical development is an incredibly important milestone for everyone involved. So far, development in the Regulus program and of the drug candidate AQ280 has been highly effective thanks to a small, unique, talented, and highly experienced team that together represent one of Aqilion’s greatest strengths,” says Sarah Fredriksson, CEO of Aqilion. “Moreover, I am both proud and pleased that we have also succeeded in establishing a pipeline with an innovative profile and a clear focus within chronic inflammatory diseases, including programs from discovery to early clinical development.”
The Phase I trial
The Phase 1 clinical trial, ARIA-1, will include 64 healthy volunteers. The purpose of the study is to investigate possible side effects and pharmacokinetics (how the body breaks down and gets rid of the substance). ARIA-1 is being conducted as a dose escalation study, which means that the trial begins with a very low dose, after which the dose is gradually increased. The primary aim of the study is to determine the tolerability and safety of AQ280, which will be evaluated in steps in one group with an escalating single dose (single ascending dose, SAD) and in another group with a repeated oral dosage over several days (multiple ascending dose, MAD). The clinical trial is being conducted in the UK with the approval of the British Medicines and Healthcare Products Regulatory Agency (MHRA). The results from the Phase 1 clinical trial are expected in the mid-2023.
Develop a next-generation JAK1 inhibitor
The aim of the Regulus program is to develop a next-generation JAK1 inhibitor. Drugs with a similar mechanism of action have demonstrated clinical efficacy in autoimmune and inflammatory diseases. Aqilion will initially test, assess, and develop the drug candidate AQ280 as a potential treatment for eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus, that is also known as “allergic esophagitis”. Once the Phase 1 clinical trial is completed, Aqilion intends to apply for drug testing prior to the Phase 2a study in patients. To date, no drugs with this mechanism of action has been developed for EoE and there is a large and growing unmet medical need.
Photo of Sarah Fredriksson: Aqilion