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CEO Letter

CEO

During the quarter, we took the major step from preclinical development to our first clinical study with the drug candidate AQ280, Regulus. The compound is primarily intended for the treatment of eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus. The disease is also known as “allergic esophagitis” and means that the patient has great difficulty swallowing. There is a great medical need for effective treatments for this patient group, which is also growing in number.

Aqilion acquired the entire Regulus drug program from LEO Pharma at the year-end of 2021/2022. Since then, the goal has been to prepare the study, without losing time, in parallel with the administrative process associated with taking over the program. We are proud and thrilled to have succeeded in maintaining the high pace that was necessary to achieve this historic event of reaching the clinical development milestone.

Regulus follows its planned schedule

The Phase 1 clinical trial of AQ280, ARIA-1, will include 64 healthy volunteers and so far, we have recruited just over half of the participants. The purpose is to investigate possible side effects and 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 objective is to establish the safety and tolerability of AQ280. The study is following its schedule and we expect a final report in Q2/Q3 2023. We then intend to apply for drug testing prior to a Phase 2a clinical study in EoE patients.

Although EoE is a disease that is on the rise in both the US and Europe, its treatments still qualify as “orphan drugs.” It is therefore important to work with a large number of clinics during the Phase 2 clinical trial in order to successfully recruit patients at an acceptable pace. As part of our preparations for a Phase 2 clinical trial, in October we participated in a symposium arranged by the European Society of Eosinophilic Oesophagitis. The purpose was to learn the latest news in EoE research, clinical trials, and treatment options. The event was also an excellent opportunity to introduce Aqilion’s Regulus program to KOLs.

Rapid development for Alnitak

During the period, we conducted an array of analyses prior to nominating a drug candidate in the Alnitak program. We also increased the pace of development of completely new compounds that can cross the blood-brain barrier, which is a challenge, since very few substances are able to cross from the bloodstream into brain tissue. Our success is crucial for us being able to nominate an additional drug candidate specifically intended for the treatment of chronic inflammatory diseases of the central nervous system, e.g., MS (multiple sclerosis).

Our comprehensive strategy for the Alnitak program is to sign a collaborative agreement or licensing agreement with a partner that in turn has the necessary resources and opportunities to conduct an optimal clinical development program. We have initiated early discussions with some chosen potential partners.

The process has intensified and resulted in in-depth encouraging talks with a few prospective partners.

Continued optimism

Last but not least, I would like to thank all of our long-term owners, partners and fantastic employees for their tremendous dedication and commitment, which have enabled Aqilion to reach the significant milestone of running our own preclinical and clinical development programs. I look forward to an exciting time ahead with continued success.

Helsingborg, Sweden, on November 24, 2022

Sarah Fredriksson, CEO and President, AQILION AB