- In our base scenario for AQ280, we estimate a peak sales potential of the order of a blockbuster, says the CEO Sarah Fredriksson.
Aqilions pipeline is built on early drug development with a focus on novel therapeutic approaches to treat diseases with limited treatment options. By leveraging the latest scientific research and strategic partnerships, the company strives to deliver transformative solutions for patients worldwide.
Advances in the treatment of eosinophilic esophagitis
Aqilion's leading program, AQ280, is being developed as a potential treatment for eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus characterized by difficulty swallowing, chest pain, and persistent inflammation. Despite the increasing prevalence of the disease, current treatment options are limited and focus primarily on symptom relief rather than addressing the underlying disease mechanisms.
AQ280, a highly selective JAK1 inhibitor, targets the inflammatory signaling pathways that drive EoE and offers a novel treatment approach. Early clinical trials have shown promising pharmacokinetics and tolerability, paving the way for Aqilion to initiate a Phase II study to further evaluate the drug's safety and efficacy in patients with EoE.
Strategic rights issue to accelerate AQ280
In order to drive the clinical development of AQ280 forward, Aqilion has initiated a rights issue to raise approximately SEK 26,8 million. Existing shareholders will receive one subscription right per share, where ten subscription rights entitle them to subscribe for three new shares at a subscription price of SEK 13 per share. The subscription period is open until March 12.
Key shareholders, including LMK Forward, The branch specialist, LEO Pharma and Nocroc Ventures, together account for approximately 38 percent of the issue.
Q&A with Aqilion's CEO
BioStock contacted the CEO Sarah Fredriksson to get more information about the ongoing rights issue and future plans.
What prompted Aqilion to focus on eosinophilic esophagitis (EoE) for the AQ280 program?
– EoE is a serious chronic disease that is becoming increasingly common and affects both children and adults. It has a huge impact on quality of life. When we were given the opportunity to acquire AQ280 from LEO Pharma, we realized that its quality and selectivity made it a strong candidate for the treatment of EoE. The mechanism of action and the potential for a wider therapeutic window – allowing for higher dosing without serious side effects – compared to established JAK1 inhibitors strengthened our decision to focus on EoE, a difficult-to-treat disease with a large unmet medical need.
What is the market potential within EoE?
– EoE is a growing market with both favorable and challenging factors that could impact AQ280's commercial potential. To account for this, we have developed several commercial scenarios that consider factors such as the competitive landscape, changing pricing and reimbursement conditions, and the overall size of the market. In our base case scenario, where AQ280 reaches a peak market share of 10 percent of the patient group eligible for advanced therapy, we estimate a peak sales potential of the order of a blockbuster.
Can you tell us more about your partnership strategy for the AQ280 program?
– We are always open to partnerships and actively build relationships as part of our business development strategy. Our goal is to secure a partnership agreement after Phase II, when we have proof-of-concept data from patients – provided the results are positive. At the same time, we are open to discussions at all stages with the right partner. The most important thing for us is to maintain the value of our intellectual property and stick to our development plan to ensure that the product reaches patients as effectively as possible.
Can you elaborate on the decision to conduct a pharmacokinetic study with the new oral solution formulation?
“EoE patients have difficulty swallowing pills or capsules. To facilitate administration for study participants, we decided after our Phase I study to develop a tablet that dissolves in water, making it easier to take.”
– During our pre-IND meeting with the FDA, we received good support and feedback on our study protocol. We also concluded that a pharmacokinetic (PK) study is a strategic risk minimization step before moving on to Phase II. This study, conducted in healthy volunteers, will confirm that the new tablet formulation has a pharmacokinetic profile comparable to the capsule used in our Phase I study.
What are Aqilion's long-term goals for the AQ280 program?
– Our primary focus is to conduct the combined Phase IIa and IIb study and demonstrate the beneficial properties and mechanism of action of AQ280 in EoE patients. We aim to complete this study by 2027. If the results are successful, we plan to enter into a partnership with a larger company for late-stage clinical development.
How do you plan to use the proceeds from the current rights issue?
– The majority of the funds will be used for the pharmacokinetic study of AQ280, which will be conducted in healthy volunteers in the US during the first half of this year. In addition, we will continue to develop our preclinical programs according to plan and invest in business development, just as we always do.