On December 3, 2021 AQILION AB (publ) reported that it has strengthened its pipeline with an innovative development program in the field of chronic inflammation (Press release, Aqilion, DEC 3, 2021, View Source [SID1234596433]). With this acquisition, Aqilion is taking over all rights to the program, now under the name Regulus, from LEO Pharma. The project is ready for clinical trials and Aqilion plans to begin clinical development in 2022.

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Aqilion has acquired all rights to Regulus from LEO Pharma, who developed the project from early internal discovery research. Under the terms of the agreement, Aqilion will make an upfront payment that is a combination of cash and equity and LEO Pharma will become a shareholder of Aqilion. Furthermore, Aqilion will make additional payments from either product sales or through out-licensing revenues.

Regulus is a novel next-generation selective JAK1 inhibitor previously developed as LEO 142397, now AQ280. Drugs with a similar mechanism of action have shown clinical efficacy in autoimmune and inflammatory diseases. Aqilion will initially investigate AQ280 as a potential therapy for eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus. To date, no drugs with the same mechanism of action have been developed for EoE and there is a high unmet medical need. Aqilion will conduct the Regulus project in-house with the aim of starting a Phase 1 safety study in healthy volunteers in 2022, followed by a Phase 2a study in patients.

"It is both gratifying and inspiring for us at Aqilion to be able to expand our chronic inflammation pipeline with such an innovative, high quality and exciting program as Regulus. Expanding our pipeline with a project in early clinical development has been a priority and we now look forward to advancing Regulus, while benefiting from synergies with our pipeline of preclinical projects," says Sarah Fredriksson, CEO of Aqilion.

"We are always excited to see our R&D operations bring forward new compounds that has the potential to help patients in any indication. In this case EoE where Aqilion is the right partner to pursue the potential of LEO 142397 – now Regulus. LEO Pharma will continue our dedication to bringing forward new innovative treatments that are either first or best in class and changing the standards of care within medical dermatology," says Thorsten Thormann, VP Research and Early Development in LEO Pharma.

About eosinophilic esophagitis
Eosinophilic esophagitis (EoE) is a rare chronic disease involving inflammation of the esophageal mucosa; its main symptom is swallowing difficulties. EoE is a relatively new diagnosis that is increasing in incidence. The disease, which has a progressive course, is also known as "allergic esophagitis" and is thought to be triggered by food allergens. Both children and adults can be affected and the diagnosis is most common in children in their teens and in adults aged 30-50. The condition is more common in men.