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Aqilion receives regulatory approval to conduct Phase 1 clinical trial

Sarah Fredriksson

Aqilion has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has approved the company’s Phase 1 clinical trial with its drug candidate AQ280.

Aqilion applied to conduct a Phase I safety study in 64 healthy volunteers with the drug candidate AQ280 within the Regulus program. The study, ARIA-1, will be conducted in the UK.

An important milestone

The purpose of the study is to investigate possible side effects and pharmacokinetics (how the body breaks down and gets rid of the substance). The study will be conducted as a dose escalation study by beginning with a very low dose and then gradually increasing the dose. ARIA-1 is planned to start in August and results are expected in the second quarter of 2023. The goal for the drug candidate AQ280 is to test it and initially evaluate it as a potential treatment for eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus.

“The Phase I clinical trial in the Regulus program is an important milestone for Aqilion, as we take the step from preclinical to clinical development. I am proud that we have effectively prepared and completed the application for the clinical study with AQ280 in such a short time. This has been our top priority since we acquired all rights to Regulus in December 2021. We want to optimally manage the high-quality work that LEO Pharma invested in the project by quickly initiating the first clinical safety study, followed by a Phase IIa study in patients,” says Sarah Fredriksson, CEO of AQILION.

Photo of Sarah Fredriksson: Aqilion